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| Dockets Entered
On January 13, 2004
Table of Contents
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| Docket #
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| Title
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| 1995N-0304
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| Ephedrine Alkaloids: Reports of Adverse Events; Availability
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| |
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| 2003N-0187
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| Agency Information Collection Activities; Submission for OMB Review; Comment Request; Postmarket Surveillence of Medical Devices
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| 2003N-0213
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| Reporting and Recordkeeping Requirements and Availability of Sample Electronic Products for Manufacturers and Distributors of Electronic Products
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| 2003N-0269
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Infectious Disease Issues in Xenotransplantation
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| 2003N-0286
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| Agency Information Collection Activities: Proposed Collection; Comment Request; User Fee Cover Sheet; Form FDA 3397
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| 2003N-0314
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements
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| 2003N-0318
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products
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| 2003N-0463
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Infant Formula Requirements
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| 2004D-0002
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| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
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| 2004E-0019
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| Patent Extension, FUZEON (enfuvirtide), U.S. Patent No. 6,133,418
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| 2004M-0012
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| P030002, crystalens Model AT-45 Accommodating Posterior Chamber Intraocular Lens (IOL),
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| 2004V-0020
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| Laser Display Device
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| 1995N-0304
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| Ephedrine Alkaloids: Reports of Adverse Events; Availability
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| EMC 965
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| D. Forsman
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| Vol #:
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| 375
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| EMC 966
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| B. Kabaservice
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| Vol #:
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| 375
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| EMC 967
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| C. Bishop
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| Vol #:
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| 375
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| EMC 968
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| P. Roundtree
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| Vol #:
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| 375
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| EMC 969
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| E. Oliva
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| Vol #:
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| 375
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| EMC 970
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| C. Bishop
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| Vol #:
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| 375
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| EMC 971
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| M. Jackman
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| Vol #:
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| 375
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| EMC 972
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| No signature
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| Vol #:
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| 375
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| |
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| EMC 973
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| G. Pouliotte
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| Vol #:
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| 375
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| |
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| EMC 974
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| S. Kendall
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| Vol #:
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| 375
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| EMC 975
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| E. Eaton
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| Vol #:
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| 375
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| EMC 976
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| T. Thornton
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| Vol #:
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| 375
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| EMC 977
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| L. Novak
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| Vol #:
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| 375
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| |
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| EMC 978
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| B. Putchio
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| Vol #:
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| 375
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| EMC 979
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| B. Mittag
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| Vol #:
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| 375
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| EMC 980
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| L. Jamason
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| Vol #:
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| 375
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| EMC 981
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| N.L. Winters
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| Vol #:
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| 375
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| EMC 982
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| K. Holmer
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| Vol #:
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| 375
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| EMC 983
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| P. Wright
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| Vol #:
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| 375
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| EMC 984
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| K. Holmer
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| Vol #:
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| 375
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| EMC 985
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| C. Shelton
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| Vol #:
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| 375
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|
| EMC 986
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| No signature
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| Vol #:
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| 375
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| EMC 987
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| B. Buckwalter
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| Vol #:
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| 375
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| EMC 988
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| K.L. Hart
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| Vol #:
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| 375
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| EMC 989
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| E. Yancey
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| Vol #:
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| 375
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| EMC 990
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| K.M. O'Dell
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| Vol #:
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| 375
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| EMC 991
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| E. Mitchell
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| Vol #:
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| 375
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| EMC 992
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| No signature
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| Vol #:
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| 375
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| EMC 993
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| P. Bonett
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| Vol #:
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| 375
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| EMC 994
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| P. Bonett
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| Vol #:
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| 375
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|
| EMC 995
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| M.E. Jones
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| Vol #:
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| 375
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| EMC 996
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| C. Bowman
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| Vol #:
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| 375
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| EMC 997
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| M. Parisa
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| Vol #:
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| 375
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| EMC 998
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| T. Weitz
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| Vol #:
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| 375
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| EMC 999
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| S.R. Simpson
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| Vol #:
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| 375
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| EMC 1000
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| K. Reynolds
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| Vol #:
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| 375
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| EMC 1001
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| J. Jimenez
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| Vol #:
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| 375
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| EMC 1002
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| S. Jones
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| Vol #:
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| 375
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| EMC 1003
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| M.L. Wethington
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| Vol #:
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| 375
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| EMC 1004
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| R. Bennett
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| Vol #:
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| 375
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| EMC 1005
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| J. Manus
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| Vol #:
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| 375
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| EMC 1006
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| P. Dobler
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| Vol #:
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| 375
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| EMC 1007
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| K. O'Dell
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| Vol #:
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| 375
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| |
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| EMC 1008
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| B. Graham
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| Vol #:
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| 375
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| EMC 1009
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| J.A. Martire
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| Vol #:
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| 375
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| EMC 1010
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| L. Vadala
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| Vol #:
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| 375
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| EMC 1011
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| R.A. Baye
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| Vol #:
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| 375
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| EMC 1012
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| K.J. Baker
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| Vol #:
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| 375
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| EMC 1013
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| K.A. Merrifield
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| Vol #:
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| 375
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| EMC 1014
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| Jean
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| Vol #:
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| 375
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| EMC 1015
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| R. Lim
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| Vol #:
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| 375
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| EMC 1016
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| C. McCollough
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| Vol #:
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| 375
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| EMC 1017
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| Randy
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| Vol #:
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| 375
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| EMC 1018
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| Yolanda
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| Vol #:
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| 375
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| |
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| EMC 1019
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| J.A. Martire
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| Vol #:
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| 375
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| |
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| EMC 1020
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| L. Hack
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| Vol #:
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| 375
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| |
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| EMC 1021
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| L. Hack
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| Vol #:
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| 375
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| |
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| EMC 1022
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| T. Simon
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| Vol #:
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| 375
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| EMC 1023
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| L. McCullough
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| Vol #:
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| 375
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| |
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| EMC 1024
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| C. Jackson
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| Vol #:
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| 375
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| |
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| EMC 1025
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| Linda B.
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| Vol #:
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| 375
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| |
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| EMC 1026
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| K. Klang
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| Vol #:
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| 375
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| |
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| EMC 1027
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| J.L. Pierson
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| Vol #:
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| 375
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| |
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| EMC 1028
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| E. Porter
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| Vol #:
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| 375
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| |
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| EMC 1029
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| T.R. Hall
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| Vol #:
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| 375
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| |
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| EMC 1030
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| D. Sanchez
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| Vol #:
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| 375
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| |
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| EMC 1031
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| No signature
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| Vol #:
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| 375
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| |
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| EMC 1032
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| B. Gerringer
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| Vol #:
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| 375
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| |
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| EMC 1033
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| No signature
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| Vol #:
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| 375
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| |
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| EMC 1034
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| No signature
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| Vol #:
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| 375
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| |
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| EMC 1035
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| No signature
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| Vol #:
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| 375
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| |
|
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| EMC 1036
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| C. Allums
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| Vol #:
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| 375
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| |
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| EMC 1037
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| K. Frisbie
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| Vol #:
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| 375
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| |
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| EMC 1038
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| J. West
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| Vol #:
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| 375
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| |
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| EMC 1039
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| C. Allums
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| Vol #:
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| 375
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| |
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| EMC 1040
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| No signature
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| Vol #:
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| 375
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| |
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| EMC 1041
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| J. Miletello
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| Vol #:
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| 375
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| |
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| EMC 1042
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| Henry
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| Vol #:
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| 375
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| |
|
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| EMC 1043
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| No signture
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| Vol #:
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| 375
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| |
|
|
| EMC 1044
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| T. Chasse
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| Vol #:
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| 375
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| |
|
|
| EMC 1045
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| J. Ford
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| Vol #:
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| 375
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| |
|
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| EMC 1046
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| A. Hart
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| Vol #:
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| 375
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| |
|
|
| EMC 1047
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| M. Knapp
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| Vol #:
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| 375
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| |
|
|
| EMC 1048
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| L. Grigsby
|
| Vol #:
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| 375
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| |
|
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| EMC 1049
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| W.B. Wulf
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| Vol #:
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| 375
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| |
|
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| EMC 1050
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| D. Baginski
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| Vol #:
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| 375
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| |
|
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| EMC 1051
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| K. Flood
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| Vol #:
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| 375
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| |
|
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| EMC 1052
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| C. Haines, III
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| Vol #:
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| 375
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| |
|
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| EMC 1053
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| No signature
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| Vol #:
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| 375
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| |
|
|
| EMC 1054
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| K. Bollom
|
| Vol #:
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| 375
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| |
|
|
| EMC 1055
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| Philip
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| Vol #:
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| 375
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| |
|
|
| EMC 1056
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| T. Duvall
|
| Vol #:
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| 375
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| |
|
|
| EMC 1057
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| G. Mason
|
| Vol #:
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| 375
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| |
|
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| EMC 1058
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| E.&S. Gann
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| Vol #:
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| 375
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| |
|
|
| EMC 1059
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| A. Hui
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| Vol #:
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| 375
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|
| | | | | | | |
| |
|
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| EMC 1060
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| A.C. Berg
|
| Vol #:
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| 375
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| |
|
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| EMC 1061
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| Dr. B. Martini
|
| Vol #:
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| 375
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| |
|
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| EMC 1062
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| S.K. Dennis
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| Vol #:
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| 375
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| |
|
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| EMC 1063
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| S. Grummett
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| Vol #:
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| 375
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| |
|
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| EMC 1064
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| C. Bowler
|
| Vol #:
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| 375
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| |
|
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| EMC 1065
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| T. Tipping
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| Vol #:
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| 375
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| |
|
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| EMC 1066
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| M. Wirtschafter
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| Vol #:
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| 375
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| |
|
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| EMC 1067
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| M. D'Ambrosio, PhD
|
| Vol #:
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| 375
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| |
|
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| EMC 1068
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| J. Astier
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| Vol #:
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| 375
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| |
|
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| EMC 1069
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| E.D. Perry
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| Vol #:
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| 375
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| |
|
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| EMC 1070
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| J. Teshka
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| Vol #:
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| 375
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| |
|
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| EMC 1071
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| A. Myrick
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| Vol #:
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| 375
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| |
|
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| EMC 1072
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| M. Cochenour
|
| Vol #:
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| 375
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| |
|
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| EMC 1073
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| R. Luedke
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| Vol #:
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| 375
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| |
|
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| EMC 1074
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| Mr. Smith
|
| Vol #:
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| 375
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| |
|
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| EMC 1075
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| T. Wheeler
|
| Vol #:
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| 375
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| |
|
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| EMC 1076
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| L. Fowler, CPA
|
| Vol #:
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| 375
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| |
|
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| EMC 1077
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| D. MArtin
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| Vol #:
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| 375
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| |
|
|
| EMC 1078
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| R. Albain
|
| Vol #:
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| 375
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| |
|
|
| EMC 1079
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| S. Donahue
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| Vol #:
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| 375
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| |
|
|
| EMC 1080
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| T. Conboy
|
| Vol #:
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| 375
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| |
|
|
| EMC 1081
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| No signature
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| Vol #:
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| 375
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| |
|
|
| EMC 1082
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| Paster V. Gerardi
|
| Vol #:
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| 375
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| |
|
|
| EMC 1083
|
| E. Mitchell
|
| Vol #:
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| 375
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| |
|
|
| EMC 1084
|
| J. Walters, R.Ph.
|
| Vol #:
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| 375
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| |
|
|
| EMC 1085
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| No signature
|
| Vol #:
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| 375
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| |
|
|
| EMC 1086
|
| J. Tozzi
|
| Vol #:
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| 375
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| |
|
|
| EMC 1087
|
| M. Morris
|
| Vol #:
|
| 375
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| |
|
|
| EMC 1088
|
| S. Moneysmith
|
| Vol #:
|
| 375
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| |
|
|
| EMC 1089
|
| B. Boop
|
| Vol #:
|
| 375
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| |
|
|
| EMC 1090
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| D. Phillips
|
| Vol #:
|
| 375
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| |
|
|
| EMC 1091
|
| J. Varuzzo
|
| Vol #:
|
| 375
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| |
|
|
| EMC 1092
|
| G. Chambers
|
| Vol #:
|
| 375
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| |
|
|
| EMC 1093
|
| No signature
|
| Vol #:
|
| 375
|
| |
|
|
| EMC 1094
|
| M. Foster
|
| Vol #:
|
| 375
|
| |
|
|
| EMC 1095
|
| M. Foster
|
| Vol #:
|
| 375
|
| |
|
|
| EMC 1096
|
| No signature
|
| Vol #:
|
| 375
|
|
| | | | | | | | |
| |
|
|
| EMC 1097
|
| H. Mutsaers
|
| Vol #:
|
| 375
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| |
|
|
| EMC 1098
|
| J. Goldenberg
|
| Vol #:
|
| 375
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| |
|
|
| EMC 1099
|
| B. Aurich
|
| Vol #:
|
| 375
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| |
|
|
| EMC 1100
|
| H.B. Williams
|
| Vol #:
|
| 375
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| |
|
|
| EMC 1101
|
| J.L. Johnson
|
| Vol #:
|
| 375
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| |
|
|
| EMC 1102
|
| D. Romero
|
| Vol #:
|
| 375
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| |
|
|
| EMC 1103
|
| K. Folsom
|
| Vol #:
|
| 375
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| |
|
|
| EMC 1104
|
| J. Theiss
|
| Vol #:
|
| 375
|
| |
|
|
| EMC 1105
|
| No signature
|
| Vol #:
|
| 375
|
| |
|
|
| EMC 1106
|
| No signature
|
| Vol #:
|
| 375
|
| |
|
|
| EMC 1107
|
| P. Vogel
|
| Vol #:
|
| 375
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| |
|
|
| EMC 1108
|
| J. Allsop
|
| Vol #:
|
| 375
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| |
|
|
| EMC 1109
|
| C. Martinez
|
| Vol #:
|
| 375
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| |
|
|
| EMC 1110
|
| T.A. Sagendorf
|
| Vol #:
|
| 375
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| |
|
|
| EMC 1111
|
| M. Reedy
|
| Vol #:
|
| 375
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| |
|
|
| EMC 1112
|
| S. Hendrickson
|
| Vol #:
|
| 375
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| |
|
|
| EMC 1113
|
| S. Hendrickson
|
| Vol #:
|
| 375
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| |
|
|
| EMC 1114
|
| K. Stanley
|
| Vol #:
|
| 375
|
| |
|
|
| EMC 1115
|
| Julie
|
| Vol #:
|
| 375
|
| |
|
|
| EMC 1116
|
| K. Durham
|
| Vol #:
|
| 375
|
| |
|
|
| EMC 1117
|
| No signature
|
| Vol #:
|
| 375
|
| |
|
|
| EMC 1118
|
| R. Cavotto
|
| Vol #:
|
| 375
|
| |
|
|
| EMC 1119
|
| M.E. Augustyn
|
| Vol #:
|
| 375
|
| |
|
|
| EMC 1120
|
| L. Holley
|
| Vol #:
|
| 375
|
| |
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
| |
|
|
| LET
12271
|
| Jarrow Formulas, Inc.
|
| Vol #:
|
| 98
|
| |
|
|
| LET
12272
|
| Jarrow Formulas, Inc.
|
| Vol #:
|
| 98
|
| |
|
|
| LET
12273
|
| Jarrow Formulas, Inc.
|
| Vol #:
|
| 98
|
| |
|
|
| LET
12274
|
| Jarrow Formulas, Inc.
|
| Vol #:
|
| 98
|
| |
|
|
| LET
12275
|
| Jarrow Formulas, Inc.
|
| Vol #:
|
| 98
|
| |
|
|
| LET
12276
|
| Jarrow Formulas, Inc.
|
| Vol #:
|
| 98
|
| |
|
|
| LET
12277
|
| Jarrow Formulas, Inc.
|
| Vol #:
|
| 98
|
| |
|
|
| LET
12278
|
| Jarrow Formulas, Inc.
|
| Vol #:
|
| 98
|
| |
|
|
| LET
12279
|
| Jarrow Formulas, Inc.
|
| Vol #:
|
| 99
|
| |
|
|
| LET
12280
|
| Jarrow Formulas, Inc.
|
| Vol #:
|
| 99
|
| |
|
|
| LET
12281
|
| Jarrow Formulas, Inc.
|
| Vol #:
|
| 99
|
|
| | | | | | | | |
| |
|
|
| LET
12282
|
| Jarrow Formulas, Inc.
|
| Vol #:
|
| 99
|
| |
|
|
| LET
12283
|
| Jarrow Formulas, Inc.
|
| Vol #:
|
| 99
|
| |
|
|
| LET
12284
|
| Jarrow Formulas, Inc.
|
| Vol #:
|
| 99
|
| |
|
|
| LET
12285
|
| Jarrow Formulas, Inc.
|
| Vol #:
|
| 99
|
| |
|
|
| LET
12286
|
| Jarrow Formulas, Inc.
|
| Vol #:
|
| 99
|
| |
|
|
| LET
12287
|
| Jarrow Formulas, Inc.
|
| Vol #:
|
| 99
|
| |
|
|
| LET
12288
|
| Jarrow Formulas, Inc.
|
| Vol #:
|
| 99
|
| |
|
|
| LET
12289
|
| Jarrow Formulas, Inc.
|
| Vol #:
|
| 99
|
| |
|
|
| LET
12290
|
| Jarrow Formulas, Inc.
|
| Vol #:
|
| 99
|
| |
|
|
| 2003N-0187
|
| Agency Information Collection Activities; Submission for OMB Review; Comment Request; Postmarket Surveillence of Medical Devices
|
| |
|
|
| NAL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| SS
1
|
| Supporting Statement
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0213
|
| Reporting and Recordkeeping Requirements and Availability of Sample Electronic Products for Manufacturers and Distributors of Electronic Products
|
| |
|
|
| NAL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| SS
1
|
| Supporting Statement
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0269
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Infectious Disease Issues in Xenotransplantation
|
| |
|
|
| NAL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| SS
1
|
| Supporting Statement
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0286
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; User Fee Cover Sheet; Form FDA 3397
|
| |
|
|
| NAL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| SS
1
|
| Supporting Statement
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0314
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements
|
| |
|
|
| NAL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| SS
1
|
| Supporting Statement
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0318
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products
|
| |
|
|
| NAL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| SS
1
|
| Supporting Statement
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0463
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Infant Formula Requirements
|
| |
|
|
| N
2
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004D-0002
|
| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
|
| |
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
| |
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
| |
|
|
| 2004E-0019
|
| Patent Extension, FUZEON (enfuvirtide), U.S. Patent No. 6,133,418
|
| |
|
|
| APP 1
|
| Duke University
|
| Vol #:
|
| 1
|
| |
|
|
| LET
1
|
| U.S. Patent & Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2004M-0012
|
| P030002, crystalens Model AT-45 Accommodating Posterior Chamber Intraocular Lens (IOL),
|
| |
|
|
| AAV
1
Approval
Order,
SS & E,
Labeling
|
| eyeonics, inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004V-0020
|
| Laser Display Device
|
| |
|
|
| VAR
1
|
| Stealth DJ's Mobile Disc Jockey Services
|
| Vol #:
|
| 1
|
|
|
