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| Dockets Entered
On December 28, 2004
Table of Contents
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| Docket #
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| Title
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| 1998N-1111
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| External Penile Rigidity Devices;Proposed Classification
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| 2000N-0504
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| Egg Safety Action Plan
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2003D-0497
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| Guidance for Industry on Pharmacogenomic Data Submissions
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| 2004D-0071
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| Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: External Penile Rigidity Devices
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| 2004D-0531
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| Guidance for Industry and FDA Staff on Class II Special Controls Guidance Document: Assisted Reproduction Laser Systems; Availability
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| 2004N-0166
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Infant Feeding Practices Study II
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| 2004N-0454
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| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
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| 2004N-0530
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| Medical Devices; Obstetrical and Gynecological Devices; Classification of the Assisted Reproduction Laser System
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| 2004N-0535
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| Agency Information Collection Activities; Proposed Collection; MedWatch: The FDA Medical Products Reporting Program; Comment Request
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| 2004N-0541
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Exports: Notification and Recordkeeping Requirements
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| 1998N-1111
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| External Penile Rigidity Devices;Proposed Classification
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| NFR
1
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| FDA
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| Vol #:
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| 1
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| 2000N-0504
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| Egg Safety Action Plan
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| EMC 922
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| V. Cassidy
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| Vol #:
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| 23
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| EMC 923
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| M. Erickson
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| Vol #:
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| 23
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| EMC 924
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| K. Tracey
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| Vol #:
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| 23
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| EMC 925
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| J and D Santone
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| Vol #:
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| 23
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| EMC 926
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| J. Paley
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| Vol #:
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| 23
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| EMC 927
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| S. Scates
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| Vol #:
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| 23
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| EMC 928
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| M. Hermann
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| Vol #:
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| 23
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|
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| EMC 929
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| O'Donnell family
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| Vol #:
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| 23
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| EMC 930
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| A. Frazier
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| Vol #:
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| 23
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| EMC 931
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| T. Sia, PhD
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| Vol #:
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| 23
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| EMC 932
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| M. Bahleda
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| Vol #:
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| 23
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| EMC 933
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| L. Avila
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| Vol #:
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| 23
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| EMC 934
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| J. Starritt
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| Vol #:
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| 23
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| EMC 935
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| R. Mathis
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| Vol #:
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| 23
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| EMC 936
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| R. Oliynik
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| Vol #:
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| 23
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|
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| EMC 937
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| Marie
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| Vol #:
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| 23
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| EMC 938
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| M. Cover
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| Vol #:
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| 23
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| EMC 939
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| L. Silverman
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| Vol #:
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| 23
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| EMC 940
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| K. Nolle
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| Vol #:
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| 23
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| EMC 941
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| S. Albert
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| Vol #:
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| 23
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| EMC 942
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| K. Smith
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| Vol #:
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| 23
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| | | | | | | |
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| EMC 943
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| A. Conley
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| Vol #:
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| 23
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| EMC 944
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| S. Albert
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| Vol #:
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| 23
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|
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| EMC 945
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| M. Land
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| Vol #:
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| 23
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| EMC 946
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| D. Bessette
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| Vol #:
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| 23
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| EMC 947
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| J. Whitaker
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| Vol #:
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| 23
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| EMC 948
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| Dr. E. Boccagna
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| Vol #:
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| 23
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|
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| EMC 949
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| N. Fox
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| Vol #:
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| 23
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|
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| EMC 950
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| M. Lucas
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| Vol #:
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| 23
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|
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| EMC 951
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| P. Perren
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| Vol #:
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| 23
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|
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| EMC 952
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| R. Glasser
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| Vol #:
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| 23
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| EMC 953
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| M. Woodfield
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| Vol #:
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| 23
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| EMC 954
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| C. Woodcock
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| Vol #:
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| 23
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| EMC 955
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| D. James
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| Vol #:
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| 23
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| EMC 956
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| P. Wright
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| Vol #:
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| 23
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| EMC 957
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| S. Oertel
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| Vol #:
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| 23
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|
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| EMC 958
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| S. Charles
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| Vol #:
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| 23
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| EMC 959
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| S. Day
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| Vol #:
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| 23
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|
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| EMC 960
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| L. Stubblefield
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| Vol #:
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| 23
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|
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| EMC 961
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| L. Cameron
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| Vol #:
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| 23
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|
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| EMC 962
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| D. Criswell
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| Vol #:
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| 23
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|
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| EMC 963
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| Dr and Mrs W. Burroughs
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| Vol #:
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| 23
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|
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| EMC 964
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| L. Meltz
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| Vol #:
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| 23
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|
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| EMC 965
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| R. Klingberg
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| Vol #:
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| 23
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|
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| EMC 966
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| S. Crawford
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| Vol #:
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| 23
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| EMC 967
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| A. Ashton
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| Vol #:
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| 23
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|
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| EMC 968
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| M. Andrew
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| Vol #:
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| 23
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|
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| EMC 969
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| K. Bierbaum
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| Vol #:
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| 23
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|
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| EMC 970
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| M and R Mazany
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| Vol #:
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| 23
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|
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| EMC 971
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| C. Lenon
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| Vol #:
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| 23
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|
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| EMC 972
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| S. Reeves
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| Vol #:
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| 23
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|
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| EMC 973
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| T. McGoldrick
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| Vol #:
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| 23
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|
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| EMC 974
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| A. Garner
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| Vol #:
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| 23
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|
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| EMC 975
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| C. Coughlin
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| Vol #:
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| 23
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|
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| EMC 976
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| L. Gilstrap
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| Vol #:
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| 23
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|
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| EMC 977
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| L. Gilstrap
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| Vol #:
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| 23
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|
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| EMC 978
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| M. Fein
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| Vol #:
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| 23
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| EMC 979
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| N. Zoulalian
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| Vol #:
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| 23
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| | | | | | | |
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| EMC 980
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| L. Higgins
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| Vol #:
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| 23
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| EMC 981
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| B. Holtz
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| Vol #:
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| 23
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|
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| EMC 982
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| J. Short
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| Vol #:
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| 23
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|
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| EMC 983
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| J. Tuccelli
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| Vol #:
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| 23
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|
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| EMC 984
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| C. Dillard
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| Vol #:
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| 23
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|
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| EMC 985
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| L. Chaoui
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| Vol #:
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| 23
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|
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| EMC 986
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| L. Bemis
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| Vol #:
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| 23
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|
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| EMC 987
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| L. Serfass
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| Vol #:
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| 23
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|
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| EMC 988
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| J. Han
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| Vol #:
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| 23
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|
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| EMC 989
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| R. Hassan
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| Vol #:
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| 23
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|
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| EMC 990
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| W. Namisnik
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| Vol #:
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| 23
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|
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| EMC 991
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| S. Cline
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| Vol #:
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| 23
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|
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| EMC 992
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| S and A Nguyen
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| Vol #:
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| 23
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|
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| EMC 993
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| K. Malley
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| Vol #:
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| 23
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|
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| EMC 994
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| D. Schultz
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| Vol #:
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| 23
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|
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| EMC 995
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| C. Hedstrom
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| Vol #:
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| 23
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|
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| EMC 996
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| M. Hiseley
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| Vol #:
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| 23
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|
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| EMC 997
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| J. Clark
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| Vol #:
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| 23
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|
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| EMC 998
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| D. Hamilton
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| Vol #:
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| 23
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|
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| EMC 999
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| J. Clark
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| Vol #:
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| 23
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|
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| EMC 1000
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| K. Malloy
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| Vol #:
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| 23
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|
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| EMC 1001
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| J. Raven
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| Vol #:
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| 23
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|
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| EMC 1002
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| V. Andrews
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| Vol #:
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| 23
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|
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| EMC 1003
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| K. Malloy
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| Vol #:
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| 23
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|
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| EMC 1004
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| P. Becker
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| Vol #:
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| 23
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|
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| EMC 1005
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| T. Tamplin
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| Vol #:
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| 23
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|
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| EMC 1006
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| A. Harper
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| Vol #:
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| 23
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|
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| EMC 1007
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| V. Christensen
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| Vol #:
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| 23
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|
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| EMC 1008
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| M. Breccia
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| Vol #:
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| 23
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|
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| EMC 1009
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| L. Wilson, M.Ed
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| Vol #:
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| 23
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|
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| EMC 1010
|
| D. Turman
|
| Vol #:
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| 23
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|
|
| EMC 1011
|
| E. Kravis, DVM
|
| Vol #:
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| 23
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|
|
| EMC 1012
|
| No signature
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| Vol #:
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| 23
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|
|
| EMC 1013
|
| P. Haley
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| Vol #:
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| 23
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|
|
| EMC 1014
|
| J. Eck
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| Vol #:
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| 23
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|
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| EMC 1015
|
| No signature
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| Vol #:
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| 23
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|
|
| EMC 1016
|
| P. Packer
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| Vol #:
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| 23
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|
| | | | | | | |
|
|
| EMC 1017
|
| D. Anzelmo
|
| Vol #:
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| 23
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|
|
| EMC 1018
|
| R. Taksel
|
| Vol #:
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| 23
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|
|
| EMC 1019
|
| M. Rufo
|
| Vol #:
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| 23
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|
|
| EMC 1020
|
| No signature
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| Vol #:
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| 23
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|
|
| EMC 1021
|
| S. Powell
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| Vol #:
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| 23
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|
|
| EMC 1022
|
| D. Walsh
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| Vol #:
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| 23
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|
|
| EMC 1023
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| No signature
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| Vol #:
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| 23
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|
|
| EMC 1024
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| P. Aranibar
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| Vol #:
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| 23
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|
|
| EMC 1025
|
| D. Morley
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| Vol #:
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| 23
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|
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| EMC 1026
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| D. Muraco
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| Vol #:
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| 23
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|
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| EMC 1027
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| G. Thomas
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| Vol #:
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| 23
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|
|
| EMC 1028
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| J. Brotman
|
| Vol #:
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| 23
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|
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| EMC 1029
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| V. Belt
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| Vol #:
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| 23
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|
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| EMC 1030
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| No signature
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| Vol #:
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| 23
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|
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| EMC 1031
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| D. Turner,CRNA,PhD
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| Vol #:
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| 23
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|
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| EMC 1032
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| B. Elwell
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| Vol #:
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| 23
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|
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| EMC 1033
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| E. Ryan
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| Vol #:
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| 23
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| EMC 1034
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| C. Cowan
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| Vol #:
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| 23
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|
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| EMC 1035
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| M. Goodman
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| Vol #:
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| 23
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| EMC 1036
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| D. Halvorson, DVM
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| Vol #:
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| 23
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| EMC 1037
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| K. Primack
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| Vol #:
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| 23
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|
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| EMC 1038
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| L. Kendrick
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| Vol #:
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| 23
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|
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| EMC 1039
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| J. Janicki
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| Vol #:
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| 23
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|
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| EMC 1040
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| P. Eck
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| Vol #:
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| 23
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|
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| EMC 1041
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| L. Sollers
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| Vol #:
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| 23
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|
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| EMC 1042
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| J. Cochran
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| Vol #:
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| 23
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| EMC 1043
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| Mr and Mrs V and J Caracci
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| Vol #:
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| 23
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| EMC 1044
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| J. Caracci
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| Vol #:
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| 23
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| EMC 1045
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| C. Bambara
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| Vol #:
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| 23
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|
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| EMC 1046
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| J. DeFrancesco
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| Vol #:
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| 23
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| EMC 1047
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| P. Austrich
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| Vol #:
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| 23
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| EMC 1048
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| Dr. G. Reinbold
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| Vol #:
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| 23
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|
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| EMC 1049
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| J. Stephens
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| Vol #:
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| 23
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| EMC 1050
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| M. Madden
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| Vol #:
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| 23
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| EMC 1051
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| No signature
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| Vol #:
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| 23
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| EMC 1052
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| J. Laughlin
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| Vol #:
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| 23
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| EMC 1053
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| K. Olesen
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| Vol #:
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| 23
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| | | | | | | |
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| EMC 1054
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| T. Hybl
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| Vol #:
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| 23
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| EMC 1055
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| Mr and Mrs J. Denison
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| Vol #:
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| 23
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|
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| EMC 1056
|
| K. Berg
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| Vol #:
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| 23
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|
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| EMC 1057
|
| D. Dearth
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| Vol #:
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| 23
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|
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| EMC 1058
|
| R. Rutkowski
|
| Vol #:
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| 23
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|
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| EMC 1059
|
| K. Firestone
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| Vol #:
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| 23
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|
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| EMC 1060
|
| C. Repeta
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| Vol #:
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| 23
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|
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| EMC 1061
|
| J. Pomies
|
| Vol #:
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| 23
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|
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| EMC 1062
|
| I. Musche
|
| Vol #:
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| 23
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|
|
| EMC 1063
|
| J. Rubach
|
| Vol #:
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| 23
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|
|
| EMC 1064
|
| S. McLean
|
| Vol #:
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| 23
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|
|
| EMC 1065
|
| J. Blankenship
|
| Vol #:
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| 23
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|
|
| EMC 1066
|
| A. Gosack
|
| Vol #:
|
| 23
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|
|
| EMC 1067
|
| M. Schulman
|
| Vol #:
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| 23
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|
|
| EMC 1068
|
| E. Morse
|
| Vol #:
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| 23
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|
|
| EMC 1069
|
| S. Lavine
|
| Vol #:
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| 23
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|
|
| EMC 1070
|
| B. Bokovitz
|
| Vol #:
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| 23
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|
|
| EMC 1071
|
| P. Dengel
|
| Vol #:
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| 24
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|
|
| EMC 1072
|
| J. Huyler
|
| Vol #:
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| 23
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|
|
| EMC 1073
|
| L. Kasai
|
| Vol #:
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| 23
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|
|
| EMC 1074
|
| S. Lashauer
|
| Vol #:
|
| 24
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|
|
| EMC 1075
|
| R. Johnston
|
| Vol #:
|
| 24
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|
|
| EMC 1076
|
| H. Wilson
|
| Vol #:
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| 24
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|
|
| EMC 1077
|
| M. Rageth
|
| Vol #:
|
| 24
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|
|
| EMC 1078
|
| L. Baldwin
|
| Vol #:
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| 24
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|
|
| EMC 1079
|
| A. Wilson
|
| Vol #:
|
| 24
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|
|
| EMC 1080
|
| C. Adhikari
|
| Vol #:
|
| 24
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|
|
| EMC 1081
|
| T. Mulanix
|
| Vol #:
|
| 23
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|
|
| EMC 1082
|
| No signature
|
| Vol #:
|
| 24
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|
|
| EMC 1083
|
| P. Kenney
|
| Vol #:
|
| 24
|
|
|
| EMC 1084
|
| L. Kligman
|
| Vol #:
|
| 24
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|
|
| EMC 1085
|
| M. McFadden
|
| Vol #:
|
| 24
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|
|
| EMC 1086
|
| J. Miebach
|
| Vol #:
|
| 24
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|
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| EMC 1087
|
| J and M Denman et al
|
| Vol #:
|
| 24
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|
|
| EMC 1088
|
| M. Nobile
|
| Vol #:
|
| 24
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|
|
| EMC 1089
|
| K. Pollock
|
| Vol #:
|
| 24
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|
|
| EMC 1090
|
| R. Meltzer
|
| Vol #:
|
| 24
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|
| | | | | | | |
|
|
| EMC 1091
|
| C. Minghella
|
| Vol #:
|
| 24
|
|
|
| EMC 1092
|
| C. Minghella
|
| Vol #:
|
| 24
|
|
|
| EMC 1093
|
| S. Utterback
|
| Vol #:
|
| 24
|
|
|
| EMC 1094
|
| D. Oshea
|
| Vol #:
|
| 24
|
|
|
| EMC 1095
|
| Mr and Mrs K. Livingston
|
| Vol #:
|
| 24
|
|
|
| EMC 1096
|
| P. Fulda
|
| Vol #:
|
| 24
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|
|
| EMC 1097
|
| S and R Riley
|
| Vol #:
|
| 24
|
|
|
| EMC 1098
|
| No signature
|
| Vol #:
|
| 24
|
|
|
| EMC 1099
|
| G. Orcholski
|
| Vol #:
|
| 24
|
|
|
| EMC 1100
|
| G. Orcholski
|
| Vol #:
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| 24
|
|
|
| EMC 1101
|
| L. Malcolmson
|
| Vol #:
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| 24
|
|
|
| EMC 1102
|
| S and R Riley
|
| Vol #:
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| 24
|
|
|
| EMC 1103
|
| E. MaCaulay
|
| Vol #:
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| 24
|
|
|
| EMC 1104
|
| L. Kelley
|
| Vol #:
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| 24
|
|
|
| EMC 1105
|
| M. Vredenburg
|
| Vol #:
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| 24
|
|
|
| EMC 1106
|
| S. Thalheimer
|
| Vol #:
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| 24
|
|
|
| EMC 1107
|
| M. Sirag
|
| Vol #:
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| 24
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|
|
| EMC 1108
|
| S. Varner
|
| Vol #:
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| 24
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|
|
| EMC 1109
|
| L. Massberg
|
| Vol #:
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| 24
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|
|
| EMC 1110
|
| J. Phillip
|
| Vol #:
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| 24
|
|
|
| EMC 1111
|
| L. Hecklinger
|
| Vol #:
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| 24
|
|
|
| EMC 1112
|
| L. Massberg
|
| Vol #:
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| 24
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|
|
| EMC 1113
|
| A. DeRoy,PhD,MPA
|
| Vol #:
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| 24
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|
|
| EMC 1114
|
| V. Johnson
|
| Vol #:
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| 24
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|
|
| EMC 1115
|
| E. Holtz
|
| Vol #:
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| 24
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|
|
| EMC 1116
|
| R. Hansraj
|
| Vol #:
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| 24
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|
|
| EMC 1117
|
| J. Fox
|
| Vol #:
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| 24
|
|
|
| EMC 1118
|
| R. Andrade
|
| Vol #:
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| 24
|
|
|
| EMC 1119
|
| N. Forgett
|
| Vol #:
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| 24
|
|
|
| EMC 1120
|
| G. Golan
|
| Vol #:
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| 24
|
|
|
| EMC 1121
|
| D. Jones
|
| Vol #:
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| 24
|
|
|
| EMC 1122
|
| E. Senyan
|
| Vol #:
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| 24
|
|
|
| EMC 1123
|
| M. Jenkins
|
| Vol #:
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| 24
|
|
|
| EMC 1124
|
| J. Fairbanks
|
| Vol #:
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| 24
|
|
|
| EMC 1125
|
| J. Niven
|
| Vol #:
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| 24
|
|
|
| EMC 1126
|
| G. Holloway
|
| Vol #:
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| 24
|
|
|
| EMC 1127
|
| C. Azelski
|
| Vol #:
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| 24
|
|
| | | | | | | |
|
|
| EMC 1128
|
| C. Erickson
|
| Vol #:
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| 24
|
|
|
| EMC 1129
|
| P. Quinn
|
| Vol #:
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| 24
|
|
|
| EMC 1130
|
| M. Schmidt
|
| Vol #:
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| 24
|
|
|
| EMC 1131
|
| L. Hahlen
|
| Vol #:
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| 24
|
|
|
| EMC 1132
|
| R. Gonzalez
|
| Vol #:
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| 24
|
|
|
| EMC 1133
|
| C. Connors
|
| Vol #:
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| 24
|
|
|
| EMC 1134
|
| S. Hawkins
|
| Vol #:
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| 24
|
|
|
| EMC 1135
|
| M. Rothman
|
| Vol #:
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| 24
|
|
|
| EMC 1136
|
| S. Shapiro
|
| Vol #:
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| 24
|
|
|
| EMC 1137
|
| F. Wax
|
| Vol #:
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| 24
|
|
|
| EMC 1138
|
| Y. Williams
|
| Vol #:
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| 24
|
|
|
| EMC 1139
|
| J. Boone
|
| Vol #:
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| 24
|
|
|
| EMC 1140
|
| J. Kaszas
|
| Vol #:
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| 24
|
|
|
| EMC 1141
|
| E. Hatleberg
|
| Vol #:
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| 24
|
|
|
| EMC 1142
|
| L. Lehr
|
| Vol #:
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| 24
|
|
|
| EMC 1143
|
| C. Bagetakos
|
| Vol #:
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| 24
|
|
|
| EMC 1144
|
| K. Veen
|
| Vol #:
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| 24
|
|
|
| EMC 1145
|
| E. Charlowski
|
| Vol #:
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| 24
|
|
|
| EMC 1146
|
| C. Smolka
|
| Vol #:
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| 24
|
|
|
| EMC 1147
|
| S. Harrington
|
| Vol #:
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| 24
|
|
|
| EMC 1148
|
| R. Winrod
|
| Vol #:
|
| 24
|
|
|
| EMC 1149
|
| C. Buker
|
| Vol #:
|
| 24
|
|
|
| EMC 1150
|
| T. Brien
|
| Vol #:
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| 24
|
|
|
| EMC 1151
|
| B. Bentley
|
| Vol #:
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| 24
|
|
|
| EMC 1152
|
| W. Rozell
|
| Vol #:
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| 24
|
|
|
| EMC 1153
|
| L. Levy
|
| Vol #:
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| 24
|
|
|
| EMC 1154
|
| J. Vido, MSW
|
| Vol #:
|
| 24
|
|
|
| EMC 1155
|
| A. Espindola, M.A.
|
| Vol #:
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| 24
|
|
|
| EMC 1156
|
| C. Tavani
|
| Vol #:
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| 24
|
|
|
| EMC 1157
|
| L. Hamilton
|
| Vol #:
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| 24
|
|
|
| EMC 1158
|
| A and N Dewis
|
| Vol #:
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| 24
|
|
|
| EMC 1159
|
| A. Hopkins
|
| Vol #:
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| 24
|
|
|
| EMC 1160
|
| J. Fench
|
| Vol #:
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| 24
|
|
|
| EMC 1161
|
| L. Mogren
|
| Vol #:
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| 24
|
|
|
| EMC 1162
|
| Dr. I. Patrick
|
| Vol #:
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| 24
|
|
|
| EMC 1163
|
| K. Himmer
|
| Vol #:
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| 24
|
|
|
| EMC 1164
|
| A. Kelman
|
| Vol #:
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| 24
|
|
| | | | | | | |
|
|
| EMC 1165
|
| R. Ordonez
|
| Vol #:
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| 24
|
|
|
| EMC 1166
|
| S. Nemati
|
| Vol #:
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| 24
|
|
|
| EMC 1167
|
| R. Hermann
|
| Vol #:
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| 24
|
|
|
| EMC 1168
|
| D. Evans
|
| Vol #:
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| 24
|
|
|
| EMC 1169
|
| D. Barnes
|
| Vol #:
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| 24
|
|
|
| EMC 1170
|
| J. Janssen
|
| Vol #:
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| 24
|
|
|
| EMC 1171
|
| M. Miles
|
| Vol #:
|
| 24
|
|
|
| EMC 1172
|
| K. Fowler
|
| Vol #:
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| 24
|
|
|
| EMC 1173
|
| R. Macrae
|
| Vol #:
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| 24
|
|
|
| EMC 1174
|
| D. Wichar
|
| Vol #:
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| 24
|
|
|
| EMC 1175
|
| Dr. M Nasif
|
| Vol #:
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| 24
|
|
|
| EMC 1176
|
| C. Moore
|
| Vol #:
|
| 24
|
|
|
| EMC 1177
|
| M. Fein
|
| Vol #:
|
| 24
|
|
|
| EMC 1178
|
| T. Soppe
|
| Vol #:
|
| 24
|
|
|
| EMC 1179
|
| C. Watt
|
| Vol #:
|
| 24
|
|
|
| EMC 1180
|
| M. VanSickle
|
| Vol #:
|
| 24
|
|
|
| EMC 1181
|
| M. Layne
|
| Vol #:
|
| 24
|
|
|
| EMC 1182
|
| T. Acuna
|
| Vol #:
|
| 24
|
|
|
| EMC 1183
|
| T. Wampler
|
| Vol #:
|
| 24
|
|
|
| EMC 1184
|
| L. Bergantino
|
| Vol #:
|
| 24
|
|
|
| EMC 1185
|
| C. Sweitzer
|
| Vol #:
|
| 24
|
|
|
| EMC 1186
|
| B. Scott
|
| Vol #:
|
| 24
|
|
|
| EMC 1187
|
| J. Teevan III
|
| Vol #:
|
| 24
|
|
|
| EMC 1188
|
| D. Adams
|
| Vol #:
|
| 24
|
|
|
| EMC 1189
|
| S. Sacks
|
| Vol #:
|
| 24
|
|
|
| EMC 1190
|
| D. Livingston
|
| Vol #:
|
| 24
|
|
|
| EMC 1191
|
| K. Lauffer
|
| Vol #:
|
| 24
|
|
|
| EMC 1192
|
| B. Bryan
|
| Vol #:
|
| 24
|
|
|
| EMC 1193
|
| H. Quirk
|
| Vol #:
|
| 24
|
|
|
| EMC 1194
|
| K. Strassman
|
| Vol #:
|
| 24
|
|
|
| EMC 1195
|
| H. Williams
|
| Vol #:
|
| 24
|
|
|
| EMC 1196
|
| D. Arias
|
| Vol #:
|
| 24
|
|
|
| EMC 1197
|
| B. Matthes
|
| Vol #:
|
| 24
|
|
|
| EMC 1198
|
| C. Diehl
|
| Vol #:
|
| 24
|
|
|
| EMC 1199
|
| C. Diehl
|
| Vol #:
|
| 24
|
|
|
| EMC 1200
|
| K. Faurest
|
| Vol #:
|
| 24
|
|
|
| EMC 1201
|
| D. Brandt
|
| Vol #:
|
| 24
|
|
| | | | | | | |
|
|
| EMC 1202
|
| J. Hills
|
| Vol #:
|
| 24
|
|
|
| EMC 1203
|
| C and R Vecchione
|
| Vol #:
|
| 24
|
|
|
| EMC 1204
|
| Y.D. Jordan
|
| Vol #:
|
| 24
|
|
|
| EMC 1205
|
| L. Dennehy
|
| Vol #:
|
| 24
|
|
|
| EMC 1206
|
| C. Hurtel
|
| Vol #:
|
| 24
|
|
|
| EMC 1207
|
| E. Kurpiel
|
| Vol #:
|
| 23
|
|
|
| EMC 1208
|
| S. Dashner
|
| Vol #:
|
| 24
|
|
|
| EMC 1209
|
| I. Sanabria
|
| Vol #:
|
| 24
|
|
|
| EMC 1210
|
| B. Arosemena
|
| Vol #:
|
| 24
|
|
|
| EMC 1211
|
| R. Zampino
|
| Vol #:
|
| 24
|
|
|
| EMC 1212
|
| K. Terrell
|
| Vol #:
|
| 24
|
|
|
| EMC 1213
|
| C. Fetterman
|
| Vol #:
|
| 24
|
|
|
| EMC 1214
|
| A. Sjogren
|
| Vol #:
|
| 24
|
|
|
| EMC 1215
|
| L. Mickens
|
| Vol #:
|
| 24
|
|
|
| EMC 1216
|
| E. Ferrari
|
| Vol #:
|
| 24
|
|
|
| EMC 1217
|
| No signature
|
| Vol #:
|
| 24
|
|
|
| EMC 1218
|
| M. LaViolette
|
| Vol #:
|
| 24
|
|
|
| EMC 1219
|
| No signature
|
| Vol #:
|
| 24
|
|
|
| EMC 1220
|
| G. Schneider
|
| Vol #:
|
| 24
|
|
|
| EMC 1221
|
| L. Zager
|
| Vol #:
|
| 24
|
|
|
| EMC 1222
|
| R. Landskroner
|
| Vol #:
|
| 24
|
|
|
| EMC 1223
|
| B. Domingo,FNP,MS
|
| Vol #:
|
| 24
|
|
|
| EMC 1224
|
| S. Figurski
|
| Vol #:
|
| 24
|
|
|
| EMC 1225
|
| A. Schoen
|
| Vol #:
|
| 24
|
|
|
| EMC 1226
|
| A. Schoen
|
| Vol #:
|
| 24
|
|
|
| EMC 1227
|
| M. Garvey
|
| Vol #:
|
| 24
|
|
|
| EMC 1228
|
| A. Beresford
|
| Vol #:
|
| 24
|
|
|
| EMC 1229
|
| K. Wessel
|
| Vol #:
|
| 24
|
|
|
| EMC 1230
|
| S. Stephenson
|
| Vol #:
|
| 24
|
|
|
| EMC 1231
|
| R. Artley
|
| Vol #:
|
| 24
|
|
|
| EMC 1232
|
| E. Fahy
|
| Vol #:
|
| 24
|
|
|
| EMC 1233
|
| S. Kimball
|
| Vol #:
|
| 24
|
|
|
| EMC 1234
|
| A. Cruise
|
| Vol #:
|
| 24
|
|
|
| EMC 1235
|
| A. Mears
|
| Vol #:
|
| 24
|
|
|
| EMC 1236
|
| P. Tanguay
|
| Vol #:
|
| 24
|
|
|
| EMC 1237
|
| J. Harris
|
| Vol #:
|
| 24
|
|
|
| EMC 1238
|
| N. Dollard
|
| Vol #:
|
| 24
|
|
| | | | | | | |
|
|
| EMC 1239
|
| S. Govoni and M. Clark
|
| Vol #:
|
| 24
|
|
|
| EMC 1240
|
| B. Gottstein
|
| Vol #:
|
| 24
|
|
|
| EMC 1241
|
| B. Atkinson
|
| Vol #:
|
| 24
|
|
|
| EMC 1242
|
| A. Carter
|
| Vol #:
|
| 24
|
|
|
| EMC 1243
|
| A. Gumula
|
| Vol #:
|
| 24
|
|
|
| EMC 1244
|
| M. Paton
|
| Vol #:
|
| 24
|
|
|
| EMC 1245
|
| L. Devine
|
| Vol #:
|
| 24
|
|
|
| EMC 1246
|
| M. Rosenthal
|
| Vol #:
|
| 24
|
|
|
| EMC 1247
|
| J. Kahl
|
| Vol #:
|
| 24
|
|
|
| EMC 1248
|
| H. Champion
|
| Vol #:
|
| 24
|
|
|
| EMC 1249
|
| C. Cording
|
| Vol #:
|
| 24
|
|
|
| EMC 1250
|
| J. Freer
|
| Vol #:
|
| 24
|
|
|
| EMC 1251
|
| P. Broda
|
| Vol #:
|
| 24
|
|
|
| EMC 1252
|
| C. Silver
|
| Vol #:
|
| 24
|
|
|
| EMC 1253
|
| Dr. B. McKnight
|
| Vol #:
|
| 24
|
|
|
| EMC 1254
|
| C. Jones
|
| Vol #:
|
| 24
|
|
|
| EMC 1255
|
| L. Manzo
|
| Vol #:
|
| 24
|
|
|
| EMC 1256
|
| H. Rayshick
|
| Vol #:
|
| 24
|
|
|
| EMC 1257
|
| S. Rayshick
|
| Vol #:
|
| 24
|
|
|
| EMC 1258
|
| No signature
|
| Vol #:
|
| 24
|
|
|
| EMC 1259
|
| R. Medley
|
| Vol #:
|
| 24
|
|
|
| EMC 1260
|
| T. Guthrie
|
| Vol #:
|
| 24
|
|
|
| EMC 1261
|
| D. Palumbo
|
| Vol #:
|
| 24
|
|
|
| EMC 1262
|
| M. Wemple, Esq
|
| Vol #:
|
| 24
|
|
|
| EMC 1263
|
| K. McAulay
|
| Vol #:
|
| 24
|
|
|
| EMC 1264
|
| A. Day
|
| Vol #:
|
| 24
|
|
|
| EMC 1265
|
| No signature
|
| Vol #:
|
| 24
|
|
|
| EMC 1266
|
| K. Edwinson
|
| Vol #:
|
| 24
|
|
|
| EMC 1267
|
| L. Fleming
|
| Vol #:
|
| 24
|
|
|
| EMC 1268
|
| R. Shapiro
|
| Vol #:
|
| 24
|
|
|
| EMC 1269
|
| J. Silber
|
| Vol #:
|
| 24
|
|
|
| EMC 1270
|
| T. Triplett
|
| Vol #:
|
| 24
|
|
|
| EMC 1271
|
| E and C Margason
|
| Vol #:
|
| 24
|
|
|
| EMC 1272
|
| B. Bramson
|
| Vol #:
|
| 24
|
|
|
| EMC 1273
|
| P. Ward
|
| Vol #:
|
| 24
|
|
|
| EMC 1274
|
| S. Goettsch
|
| Vol #:
|
| 24
|
|
|
| EMC 1275
|
| N. Waller
|
| Vol #:
|
| 24
|
|
| | | | | | | |
|
|
| EMC 1276
|
| S and R Walters
|
| Vol #:
|
| 24
|
|
|
| EMC 1277
|
| C. Allen
|
| Vol #:
|
| 24
|
|
|
| EMC 1278
|
| R. Domingues
|
| Vol #:
|
| 24
|
|
|
| EMC 1279
|
| M. Donato
|
| Vol #:
|
| 24
|
|
|
| EMC 1280
|
| M. Thomas and J Synnestvedt
|
| Vol #:
|
| 24
|
|
|
| EMC 1281
|
| M and J Gillono
|
| Vol #:
|
| 24
|
|
|
| EMC 1282
|
| S. Welch
|
| Vol #:
|
| 24
|
|
|
| EMC 1283
|
| A. Ivey
|
| Vol #:
|
| 24
|
|
|
| EMC 1284
|
| J. Ross
|
| Vol #:
|
| 24
|
|
|
| EMC 1285
|
| P. Greene
|
| Vol #:
|
| 24
|
|
|
| EMC 1286
|
| F. Kuhn
|
| Vol #:
|
| 24
|
|
|
| EMC 1287
|
| M. Moneypenny
|
| Vol #:
|
| 24
|
|
|
| EMC 1288
|
| C. Buslot
|
| Vol #:
|
| 24
|
|
|
| EMC 1289
|
| T. Gelfand, PhD
|
| Vol #:
|
| 24
|
|
|
| EMC 1290
|
| A. Brockett
|
| Vol #:
|
| 24
|
|
|
| EMC 1291
|
| D. Wanyo
|
| Vol #:
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| EMC 1292
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| R. Sambruna, PhD
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| EMC 1293
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| C. Kiser
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| EMC 1294
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| C. Byrne
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| EMC 1295
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| R. Richardson
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| EMC 1296
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| A. Soldon
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| EMC 1297
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| C and L McKibben
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| EMC 1298
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| S. Satyapal, PhD
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| EMC 1299
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| A. Soldon
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| EMC 1300
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| K. Daniels
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| EMC 1301
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| M and M Herink
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| EMC 1302
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| No signature
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| EMC 1303
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| S. Elliott
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| EMC 1304
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| K. McGovern
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| EMC 1305
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| A. Buttrey
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| EMC 1306
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| T. Zaparanick
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| EMC 1307
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| No signature
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| EMC 1308
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| E. Billeaud
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| EMC 1309
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| E. Snitzer
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| EMC 1310
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| J. Williams
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| EMC 1311
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| A. Levy
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| EMC 1312
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| L. Rizzo
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| EMC 1313
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| E. Kiefer, RN
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| EMC 1314
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| E. Hall
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| EMC 1315
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| D. Donato
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| EMC 1316
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| No signature
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| EMC 1317
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| J. Kavanagh
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| EMC 1318
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| S. Selznick
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| EMC 1319
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| J. Fitzwater
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| EMC 1320
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| D. Weingarten
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| EMC 1321
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| L. Rose
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| EMC 1322
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| G. Janzen
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| EMC 1323
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| C and D Ewing
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| EMC 1324
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| H. Savino
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| EMC 1325
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| E. Baione
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| EMC 1326
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| E. Massoth
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| EMC 1327
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| L. Baumann
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| EMC 1328
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| J. Waechter
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| EMC 1329
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| S. Farrin
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| EMC 1330
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| C. Evans
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| EMC 1331
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| S. Farrin
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| EMC 1332
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| No signature
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| EMC 1333
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| E. DuCoeur
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| EMC 1334
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| N. Lohmar
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| EMC 1335
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| J. LaVine
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| EMC 1336
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| S. Watson
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| EMC 1337
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| A. Dillon
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| EMC 1338
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| D. Demetrio
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| EMC 1339
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| D. Clark
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| EMC 1340
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| C. Moreno
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| EMC 1341
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| D. Elliott and C. Delisio
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| EMC 1342
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| S. Saliga
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| EMC 1343
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| M. Blackwell
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| EMC 1344
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| C. Lynch
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| EMC 1345
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| B. Lambros
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| EMC 1346
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| M. Azar
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| EMC 1347
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| P. Kaczmarek
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| EMC 1348
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| S. Walsh
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| EMC 1349
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| R. Douglas
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| EMC 1350
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| W. Kerr
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| EMC 1351
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| A. Lewis
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| EMC 1352
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| Dr. E. Macmillan
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| EMC 1353
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| K. Esch
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| EMC 1354
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| A. Martin
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| EMC 1355
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| M. Morrison
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| EMC 1356
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| L. Page
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| 24
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| EMC 1357
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| S and B Damon
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| 24
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| EMC 1358
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| M. Perkins
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| 24
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| EMC
1359
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| Rose Acre Farms, Inc.
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| 24
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| EMC 1360
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| R. Sherman
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| EMC 1361
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| The Nelsons
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| 24
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| EMC 1362
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| G. Primack
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| 24
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| EMC 1363
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| J. Mainiero
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| 24
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| EMC 1364
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| C. Crimi
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| 24
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| EMC 1365
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| No signature
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| 24
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| EMC 1366
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| K. Epstein
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| 24
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| EMC 1367
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| J. Ridolfi
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| 24
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| EMC 1368
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| RJ and D. Kamprath
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| 24
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| EMC 1369
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| L. Lucas
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| 24
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| EMC 1370
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| D. Klingenberg
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| 24
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| EMC 1371
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| J. Perlman, PhD
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| 24
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| EMC 1372
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| J. Hitt
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| 24
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| EMC 1373
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| J. Hitt
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| 24
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| EMC 1374
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| D. Lynn
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| 24
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| EMC 1375
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| C. Murray
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| 24
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| EMC 1376
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| K. Morgan
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| EMC 1377
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| D. Berriman
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| EMC 1378
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| A. Levine
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| 24
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| EMC 1379
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| I. Cowan
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| 24
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| EMC 1380
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| C. Summerville
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| 24
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| EMC 1381
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| J. Letard
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| Vol #:
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| 24
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| EMC 1382
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| G. Werner
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| 24
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| EMC 1383
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| L. Hardy
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| Vol #:
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| 24
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| EMC 1384
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| C. Hobbs
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| Vol #:
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| 24
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| EMC 1385
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| No signature
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| 24
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| EMC 1386
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| C. Bee
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| 24
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| EMC 1387
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| No signature
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| Vol #:
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| 24
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| EMC 1388
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| T. Price
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| Vol #:
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| 24
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| EMC 1389
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| C. Atkins
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| Vol #:
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| 24
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| EMC 1390
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| J. Hutchinson
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| Vol #:
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| 24
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| EMC 1391
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| C. Baird
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| Vol #:
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| 24
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| EMC 1392
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| No signature
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| Vol #:
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| 24
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| EMC 1393
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| M and A Waltien
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| Vol #:
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| 24
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| EMC 1394
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| J. Sullivan
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| Vol #:
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| 24
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| EMC 1395
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| J. Singh
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| Vol #:
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| 24
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| EMC 1396
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| K. Turner
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| Vol #:
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| 24
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| EMC 1397
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| N. Thompson, PhD. JD
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| Vol #:
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| 24
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| EMC
1398
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| United States Animal Health Assn (USAHA)
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| 24
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| EMC 1399
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| C. Paulus
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| Vol #:
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| 24
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| EMC 1400
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| P. Morello
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| Vol #:
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| 24
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| EMC 1401
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| S. Bedrick
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| Vol #:
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| 24
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| EMC 1402
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| S. Dzienius
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| Vol #:
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| 24
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| EMC 1403
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| A. Glick
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| 24
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| EMC 1404
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| L. Misirlic
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| Vol #:
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| 24
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| EMC 1405
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| R. Tierney
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| 24
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| EMC 1406
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| K. Campbell
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| Vol #:
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| 24
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| EMC 1407
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| G. Sarkisian
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| 24
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| EMC 1408
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| P. Dematteis
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| 24
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| EMC 1409
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| K. Thymius
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| 24
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|
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| EMC 1410
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| J. Kaden
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| Vol #:
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| 24
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| EMC 1411
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| J. Miller
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| Vol #:
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| 24
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| EMC 1412
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| M. Conlan
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| Vol #:
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| 24
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| EMC 1413
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| N. Smith
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| Vol #:
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| 24
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| EMC 1414
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| J. Martinez
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| Vol #:
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| 24
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| EMC 1415
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| J. Affleck
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| Vol #:
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| 24
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| EMC 1416
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| J. Gambarini
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| Vol #:
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| 24
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| EMC 1417
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| Nikki
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| Vol #:
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| 24
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|
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| EMC 1418
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| No signature
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| Vol #:
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| 24
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| EMC 1419
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| R. Sanders, PhD
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| Vol #:
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| 24
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|
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| EMC 1420
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| T. Edlund
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| Vol #:
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| 24
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|
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| EMC 1421
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| No signature
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| Vol #:
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| 24
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|
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| EMC 1422
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| M. Spiegel
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| Vol #:
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| 24
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|
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| EMC 1423
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| E. Tampe
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| Vol #:
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| 24
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| | | | | | | |
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| EMC 1424
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| T. Troy
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| Vol #:
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| 24
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|
|
| EMC 1425
|
| I Marsh
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| Vol #:
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| 24
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|
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| EMC 1426
|
| L. Sppiegler
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| Vol #:
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| 24
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|
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| EMC 1427
|
| M. Kennelly
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| Vol #:
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| 24
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|
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| EMC 1428
|
| N. Lane
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| Vol #:
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| 24
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|
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| EMC 1429
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| A. Welde
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| Vol #:
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| 24
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|
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| EMC 1430
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| No signature
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| Vol #:
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| 24
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|
|
| EMC 1431
|
| M. Thamer
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| Vol #:
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| 24
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|
|
| EMC 1432
|
| K. Eastin
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| Vol #:
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| 24
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|
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| EMC 1433
|
| K. Bremer
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| Vol #:
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| 24
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|
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| EMC 1434
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| No signature
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| Vol #:
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| 24
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|
|
| EMC 1435
|
| Mr and Mrs T. B. Robinson
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| Vol #:
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| 24
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|
|
| EMC 1436
|
| B. Stauber
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| Vol #:
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| 24
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|
|
| EMC 1437
|
| C. Borra
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| Vol #:
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| 24
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|
|
| EMC 1438
|
| L. Kothe, Esq
|
| Vol #:
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| 24
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|
|
| EMC 1439
|
| E. Stark and Richard weber
|
| Vol #:
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| 24
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|
|
| EMC 1440
|
| S. Buazard
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| Vol #:
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| 24
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|
|
| EMC 1441
|
| D. Fleming, PhD
|
| Vol #:
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| 24
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|
|
| EMC 1442
|
| S. Smith
|
| Vol #:
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| 24
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|
|
| EMC 1443
|
| G. Carlsen
|
| Vol #:
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| 24
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|
|
| EMC 1444
|
| M. Mayers
|
| Vol #:
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| 24
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|
|
| EMC 1445
|
| M. Moerenhout
|
| Vol #:
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| 24
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|
|
| EMC 1446
|
| J. Jasper
|
| Vol #:
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| 24
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|
|
| EMC 1447
|
| C. Komisarz
|
| Vol #:
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| 24
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|
|
| EMC 1448
|
| B. Ackerman
|
| Vol #:
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| 24
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|
|
| EMC 1449
|
| Dr. G III and B. Ballard
|
| Vol #:
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| 24
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|
|
| EMC 1450
|
| L. Howe
|
| Vol #:
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| 24
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|
|
| EMC 1451
|
| A. Borgueta
|
| Vol #:
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| 24
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|
|
| EMC 1452
|
| B. Herner
|
| Vol #:
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| 24
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|
|
| EMC 1453
|
| T. Jaarsma
|
| Vol #:
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| 24
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|
|
| EMC 1454
|
| M. Cook
|
| Vol #:
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| 24
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|
|
| EMC 1455
|
| D. Howe
|
| Vol #:
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| 24
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|
|
| EMC 1456
|
| A. Sherman
|
| Vol #:
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| 24
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|
|
| EMC 1457
|
| G. Seoane
|
| Vol #:
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| 24
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|
|
| EMC 1458
|
| No signature
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| Vol #:
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| 24
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|
|
| EMC 1459
|
| No signature
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| Vol #:
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| 24
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|
|
| EMC 1460
|
| D. Stipanovich
|
| Vol #:
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| 24
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|
| | | | | | | | |
|
|
| EMC 1461
|
| No signature
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| Vol #:
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| 24
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|
|
| EMC 1462
|
| V. Stack
|
| Vol #:
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| 24
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|
|
| EMC 1463
|
| R. Grover
|
| Vol #:
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| 24
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|
|
| EMC 1464
|
| L. Jenkins
|
| Vol #:
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| 24
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|
|
| EMC 1465
|
| S. Hardy
|
| Vol #:
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| 24
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|
|
| EMC 1466
|
| S. Materi
|
| Vol #:
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| 24
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|
|
| EMC 1467
|
| J. Martin
|
| Vol #:
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| 24
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|
|
| EMC 1468
|
| T. Siskind, RN
|
| Vol #:
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| 24
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|
|
| EMC 1469
|
| P. Johnson
|
| Vol #:
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| 24
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|
|
| EMC 1470
|
| K. Garbato
|
| Vol #:
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| 24
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|
|
| EMC 1471
|
| D. Sullivan
|
| Vol #:
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| 24
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|
|
| EMC 1472
|
| B. Stone
|
| Vol #:
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| 25
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|
|
| EMC 1473
|
| L. Danaan
|
| Vol #:
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| 25
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|
|
| EMC 1474
|
| L. Verruni
|
| Vol #:
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| 25
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|
|
| EMC 1475
|
| B. Gartland
|
| Vol #:
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| 25
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|
|
| EMC 1476
|
| K. MacKay
|
| Vol #:
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| 25
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|
|
| EMC 1477
|
| Suzannne H.
|
| Vol #:
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| 25
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|
|
| EMC 1478
|
| F. Jones
|
| Vol #:
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| 25
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|
|
| EMC 1479
|
| W. Borowsky
|
| Vol #:
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| 25
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|
|
| EMC 1480
|
| S. Kimball
|
| Vol #:
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| 25
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|
|
| EMC 1481
|
| N. Schafer
|
| Vol #:
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| 25
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|
|
| EMC 1482
|
| A. Gackowski
|
| Vol #:
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| 25
|
|
|
| EMC 1483
|
| J. Breslauer
|
| Vol #:
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| 25
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|
|
| EMC 1484
|
| I. Brintz
|
| Vol #:
|
| 25
|
|
|
| EMC 1485
|
| J. Fotos
|
| Vol #:
|
| 25
|
|
|
| EMC 1486
|
| R. Dalmau
|
| Vol #:
|
| 25
|
|
|
| EMC 1487
|
| E. Friedman
|
| Vol #:
|
| 25
|
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
|
|
| EXB 772
|
| Bayer Corporation
|
| Vol #:
|
| 469
|
|
|
| EXB 773
|
| Bayer Corporation
|
| Vol #:
|
| 469
|
|
|
| EXB 774
|
| Bayer Corporation
|
| Vol #:
|
| 469
|
|
|
| EXB 775
|
| Bayer Corporation
|
| Vol #:
|
| 469
|
|
|
| 2003D-0497
|
| Guidance for Industry on Pharmacogenomic Data Submissions
|
|
|
| NAL
1
|
| FDA
|
| Vol #:
|
| 2
|
|
|
| SS
1
|
| Supporting Statement
|
| Vol #:
|
| 2
|
|
| | | | | | | | |
|
|
| 2004D-0071
|
| Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: External Penile Rigidity Devices
|
|
|
| GDL
2
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
| NAD
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004D-0531
|
| Guidance for Industry and FDA Staff on Class II Special Controls Guidance Document: Assisted Reproduction Laser Systems; Availability
|
|
|
| GDL
1
|
| Background Material
|
| Vol #:
|
| 1
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004N-0166
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Infant Feeding Practices Study II
|
|
|
| NAL
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| SS
1
|
| Supporting Statement
|
| Vol #:
|
| 1
|
|
|
| 2004N-0454
|
| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
|
|
|
| NEC
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004N-0530
|
| Medical Devices; Obstetrical and Gynecological Devices; Classification of the Assisted Reproduction Laser System
|
|
|
| NFR
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004N-0535
|
| Agency Information Collection Activities; Proposed Collection; MedWatch: The FDA Medical Products Reporting Program; Comment Request
|
|
|
| BKG 1
|
| Background
|
| Vol #:
|
| 1
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004N-0541
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Exports: Notification and Recordkeeping Requirements
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|