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| Dockets Entered
On March 24, 2004
Table of Contents
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| Docket #
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| Title
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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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| 2000D-1314
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| Intent to Slaughter for Human Food Purposes
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| |
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| 2000N-1449
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| Changes to an Approved NDA or ANDA; Agency Information Collection
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| |
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| |
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| 2004D-0082
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| Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection Systems; Availability
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| 2004N-0101
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents; and Requiremen
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| 2004P-0044
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| de nova Classification of Factor V Leiden Kit
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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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| LET
13407
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| Nutronix International
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| Vol #:
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| 111
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| LET
13408
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| Nutronix International
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| Vol #:
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| 111
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| |
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| LET
13409
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| Nutronix International
|
| Vol #:
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| 111
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| |
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| LET
13410
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| The Vitamin Shoppe Industries, Inc.
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| Vol #:
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| 111
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| |
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| LET
13411
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| Food Distrubution Laboratory Corporation
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| Vol #:
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| 111
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| |
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| LET
13412
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 111
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| |
|
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| 2000D-1314
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| Intent to Slaughter for Human Food Purposes
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| |
|
|
| NAL
1
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| FDA
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| Vol #:
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| 1
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| |
|
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| NAL 2
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| Number not used
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| Vol #:
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| 1
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| |
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| SS
1
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| Supporting Statement
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| Vol #:
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| 1
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| |
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|
| 2000N-1449
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| Changes to an Approved NDA or ANDA; Agency Information Collection
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| |
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|
| N
4
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| FDA
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| Vol #:
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| 1
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| |
|
|
| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| |
|
|
| C 662
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| V. George, MD
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| Vol #:
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| 203
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| |
|
|
| C 663
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| V. Frazzetta
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| Vol #:
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| 203
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| |
|
|
| C 664
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| M.R. and E. Bruton
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| Vol #:
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| 203
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| |
|
|
| C 665
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| M. Litutti
|
| Vol #:
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| 203
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| |
|
|
| C 666
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| Illegible
|
| Vol #:
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| 203
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| |
|
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| C 667
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| W and N Huff
|
| Vol #:
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| 203
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| |
|
|
| C 668
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| A. Galioto
|
| Vol #:
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| 203
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| |
|
|
| C 669
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| J. Delaney
|
| Vol #:
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| 203
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| |
|
|
| C 670
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| R. Shooner, Jr.
|
| Vol #:
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| 203
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| |
|
|
| C 671
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| J. Putre
|
| Vol #:
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| 203
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| |
|
|
| C 672
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| Illegible
|
| Vol #:
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| 203
|
| |
|
|
| C 673
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| E. Jurick
|
| Vol #:
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| 203
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|
| | | | | | | |
| |
|
|
| C 674
|
| C. Dailey
|
| Vol #:
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| 203
|
| |
|
|
| C 675
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| D. Borko
|
| Vol #:
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| 203
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| |
|
|
| C 676
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| I. Barreras
|
| Vol #:
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| 203
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| |
|
|
| C 677
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| Illegible
|
| Vol #:
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| 203
|
| |
|
|
| C 678
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| C. Freitag
|
| Vol #:
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| 203
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| |
|
|
| C 679
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| R. Norton
|
| Vol #:
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| 203
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| |
|
|
| C
680
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| Reproductive Endocrinologists,
PC
|
| Vol #:
|
| 203
|
| |
|
|
| C 681
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| E. Gurda
|
| Vol #:
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| 203
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| |
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| C 682
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| Lauren
|
| Vol #:
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| 203
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| C 683
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| R. Linn
|
| Vol #:
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| 203
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| |
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| C
684
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| University of Colorado Health Sciences Center
|
| Vol #:
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| 203
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| |
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|
| C 685
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| S. Gordon
|
| Vol #:
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| 203
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| |
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| C
686
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| Physicians East, PA
|
| Vol #:
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| 203
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| |
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|
| C
687
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| Upstate Medical University
|
| Vol #:
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| 203
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| |
|
|
| C 688
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| L. Reich, DO
|
| Vol #:
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| 203
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| |
|
|
| C
689
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| National Assn of Nurse Practitioners in Women's Health (NPWH)
|
| Vol #:
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| 203
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| |
|
|
| C 690
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| V. Edwards
|
| Vol #:
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| 203
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| |
|
|
| C
691
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| Emory University School of Medicine
|
| Vol #:
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| 203
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| |
|
|
| C 692
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| Danny
|
| Vol #:
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| 203
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| |
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| C 693
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| G. Missey
|
| Vol #:
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| 203
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| |
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| C 694
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| Illegible
|
| Vol #:
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| 203
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| |
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| C 695
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| M. Prize
|
| Vol #:
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| 203
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| |
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| C 696
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| A. Gurda
|
| Vol #:
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| 203
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| |
|
|
| C 697
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| V. Pirkle,MD,FACOG
|
| Vol #:
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| 203
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| |
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| C 698
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| D. Halbig
|
| Vol #:
|
| 203
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| |
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| C 699
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| R. McCracken
|
| Vol #:
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| 203
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| |
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| C 700
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| S. Dimick
|
| Vol #:
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| 203
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| |
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| C 701
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| J. Yao
|
| Vol #:
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| 203
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| |
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| C 702
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| T. Welke
|
| Vol #:
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| 203
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| |
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| C 703
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| R. Dean
|
| Vol #:
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| 203
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| |
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| C 704
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| A. Sheppard
|
| Vol #:
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| 203
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| |
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| C 705
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| D. Hays
|
| Vol #:
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| 203
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| |
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| C 706
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| B. Hansen
|
| Vol #:
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| 203
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| |
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| C 707
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| M. Stone
|
| Vol #:
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| 203
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| |
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| C 708
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| E. Medeiros
|
| Vol #:
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| 203
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| |
|
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| C 709
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| R. Wilson
|
| Vol #:
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| 203
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| |
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| C 710
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| Y. Brown
|
| Vol #:
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| 203
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|
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| |
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| C 711
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| D. Hoelscher
|
| Vol #:
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| 203
|
| |
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|
| C 712
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| K. Savini
|
| Vol #:
|
| 203
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| |
|
|
| C 713
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| A. Kahn
|
| Vol #:
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| 203
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| |
|
|
| C 714
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| A and B. Tescher
|
| Vol #:
|
| 203
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| |
|
|
| C 715
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| R. Moore
|
| Vol #:
|
| 203
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| |
|
|
| C 716
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| A. Schmidt
|
| Vol #:
|
| 203
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| |
|
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| C 717
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| B. Paprocki
|
| Vol #:
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| 203
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| |
|
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| C 718
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| E. Castleman
|
| Vol #:
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| 203
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| |
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| C 719
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| B. Sexton
|
| Vol #:
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| 203
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| |
|
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| C 720
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| D. Hall
|
| Vol #:
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| 203
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| |
|
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| C 721
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| M. Rosswurm
|
| Vol #:
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| 203
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| |
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| C 722
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| A. Kiefer
|
| Vol #:
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| 203
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| |
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| C 723
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| L. Cole
|
| Vol #:
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| 203
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| |
|
|
| C 724
|
| L. Vandiver
|
| Vol #:
|
| 203
|
| |
|
|
| C 725
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| J. Sinsky,MD,FACOG
|
| Vol #:
|
| 203
|
| |
|
|
| C 726
|
| M. LaCourt
|
| Vol #:
|
| 203
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| |
|
|
| C 727
|
| H. Friesen,MD
|
| Vol #:
|
| 203
|
| |
|
|
| C 728
|
| P. Scherer
|
| Vol #:
|
| 203
|
| |
|
|
| C 729
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| D. Walks, MD
|
| Vol #:
|
| 203
|
| |
|
|
| C 730
|
| A. Murnane,MD,FACOG
|
| Vol #:
|
| 203
|
| |
|
|
| C 731
|
| B. Coggins
|
| Vol #:
|
| 203
|
| |
|
|
| C 732
|
| G. Gilg
|
| Vol #:
|
| 203
|
| |
|
|
| C 733
|
| R. Borges
|
| Vol #:
|
| 203
|
| |
|
|
| C 734
|
| Illegible
|
| Vol #:
|
| 203
|
| |
|
|
| C 735
|
| D. Beck
|
| Vol #:
|
| 203
|
| |
|
|
| C 736
|
| V. Carilo
|
| Vol #:
|
| 203
|
| |
|
|
| C 737
|
| J. Cromer
|
| Vol #:
|
| 203
|
| |
|
|
| C 738
|
| J. Poe
|
| Vol #:
|
| 203
|
| |
|
|
| C 739
|
| R. Tobias
|
| Vol #:
|
| 203
|
| |
|
|
| C 740
|
| J. Hyland
|
| Vol #:
|
| 203
|
| |
|
|
| C 741
|
| E. Stanton
|
| Vol #:
|
| 203
|
| |
|
|
| C 742
|
| P. Rooney
|
| Vol #:
|
| 203
|
| |
|
|
| C 743
|
| E. Carlsson
|
| Vol #:
|
| 2
|
| |
|
|
| C 744
|
| K. Meyer
|
| Vol #:
|
| 203
|
| |
|
|
| C 745
|
| R. Feeney
|
| Vol #:
|
| 203
|
| |
|
|
| C 746
|
| F. Hurley
|
| Vol #:
|
| 203
|
| |
|
|
| C 747
|
| A. Sanders
|
| Vol #:
|
| 203
|
|
| | | | | | | |
| |
|
|
| C
748
|
| Texas House of Representatives
|
| Vol #:
|
| 203
|
| |
|
|
| C 749
|
| J. Blum
|
| Vol #:
|
| 203
|
| |
|
|
| C
750
|
| Gynecology Associates
|
| Vol #:
|
| 203
|
| |
|
|
| C
751
|
| St. Philip Neri Church
|
| Vol #:
|
| 204
|
| |
|
|
| C 752
|
| J. Walker, MD
|
| Vol #:
|
| 204
|
| |
|
|
| C 753
|
| W. Williams
|
| Vol #:
|
| 204
|
| |
|
|
| C 754
|
| J. Jo
|
| Vol #:
|
| 204
|
| |
|
|
| C 755
|
| C. Deputy
|
| Vol #:
|
| 204
|
| |
|
|
| C 756
|
| P. Shuffer, MD
|
| Vol #:
|
| 204
|
| |
|
|
| C 757
|
| J. Russ
|
| Vol #:
|
| 204
|
| |
|
|
| C
758
|
| Catholic Bishops of Texas
|
| Vol #:
|
| 204
|
| |
|
|
| C 759
|
| S. Long
|
| Vol #:
|
| 204
|
| |
|
|
| C 760
|
| M and C Ullrich
|
| Vol #:
|
| 204
|
| |
|
|
| C
761
|
| Cornerstone Clinic, Ltd
|
| Vol #:
|
| 204
|
| |
|
|
| C 762
|
| D and G Cranston
|
| Vol #:
|
| 204
|
| |
|
|
| C 763
|
| R. Incantalupo
|
| Vol #:
|
| 204
|
| |
|
|
| C 764
|
| C. Telesca
|
| Vol #:
|
| 204
|
| |
|
|
| C 765
|
| V. Gall
|
| Vol #:
|
| 204
|
| |
|
|
| C 766
|
| E. Deacetis
|
| Vol #:
|
| 204
|
| |
|
|
| C 767
|
| J. Walker
|
| Vol #:
|
| 204
|
| |
|
|
| C 768
|
| M. Scotto
|
| Vol #:
|
| 204
|
| |
|
|
| C 769
|
| G. Ciotta
|
| Vol #:
|
| 204
|
| |
|
|
| C 770
|
| H. Bottum
|
| Vol #:
|
| 204
|
| |
|
|
| C 771
|
| N. Paff
|
| Vol #:
|
| 204
|
| |
|
|
| C 772
|
| M. Nourie
|
| Vol #:
|
| 204
|
| |
|
|
| C 773
|
| G. Waechter
|
| Vol #:
|
| 204
|
| |
|
|
| C 774
|
| K. Senger
|
| Vol #:
|
| 204
|
| |
|
|
| C 775
|
| L. Lopez
|
| Vol #:
|
| 204
|
| |
|
|
| C 776
|
| R. Rheinheimer
|
| Vol #:
|
| 204
|
| |
|
|
| C 777
|
| C. Harvey
|
| Vol #:
|
| 204
|
| |
|
|
| C 778
|
| P. Kwong, R.Ph
|
| Vol #:
|
| 204
|
| |
|
|
| C 779
|
| J. O'Boyle
|
| Vol #:
|
| 204
|
| |
|
|
| C 780
|
| P. Sharify
|
| Vol #:
|
| 204
|
| |
|
|
| C 781
|
| E. Oharo
|
| Vol #:
|
| 204
|
| |
|
|
| C 782
|
| M. Placke
|
| Vol #:
|
| 204
|
| |
|
|
| C 783
|
| M. Wong
|
| Vol #:
|
| 204
|
| |
|
|
| C 784
|
| D. Cary
|
| Vol #:
|
| 204
|
|
| | | | | | | |
| |
|
|
| C 785
|
| Illegible
|
| Vol #:
|
| 204
|
| |
|
|
| C 786
|
| G. Knoll
|
| Vol #:
|
| 204
|
| |
|
|
| C 787
|
| J. Kammer
|
| Vol #:
|
| 204
|
| |
|
|
| C 788
|
| E. Schwarz,MD,MS
|
| Vol #:
|
| 204
|
| |
|
|
| C 789
|
| C. Tobitsch and M. Smith
|
| Vol #:
|
| 204
|
| |
|
|
| C 790
|
| Illegible
|
| Vol #:
|
| 204
|
| |
|
|
| C 791
|
| S. Hellmer
|
| Vol #:
|
| 204
|
| |
|
|
| C 792
|
| M. Bodden
|
| Vol #:
|
| 204
|
| |
|
|
| C 793
|
| R and J. Short
|
| Vol #:
|
| 204
|
| |
|
|
| C 794
|
| T. McGovern
|
| Vol #:
|
| 204
|
| |
|
|
| C 795
|
| R. Bruno
|
| Vol #:
|
| 204
|
| |
|
|
| C 796
|
| R. Relli
|
| Vol #:
|
| 204
|
| |
|
|
| C 797
|
| A. and G Smith
|
| Vol #:
|
| 204
|
| |
|
|
| C 798
|
| D. Taylor
|
| Vol #:
|
| 204
|
| |
|
|
| C
799
|
| Washington University in St. Louis School of Medicine
|
| Vol #:
|
| 204
|
| |
|
|
| C 800
|
| H. Szgalsky
|
| Vol #:
|
| 204
|
| |
|
|
| C
801
|
| Woodbury Family Practice Asscoiates, PA
|
| Vol #:
|
| 204
|
| |
|
|
| C 802
|
| M. Kannenberg
|
| Vol #:
|
| 204
|
| |
|
|
| C 803
|
| A. Chet
|
| Vol #:
|
| 204
|
| |
|
|
| C 804
|
| L. Want
|
| Vol #:
|
| 204
|
| |
|
|
| C 805
|
| F. Dias
|
| Vol #:
|
| 204
|
| |
|
|
| C 806
|
| J. Bessette
|
| Vol #:
|
| 204
|
| |
|
|
| C 807
|
| J. Revelas
|
| Vol #:
|
| 204
|
| |
|
|
| EMC 5062
|
| M. McGilligan
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5063
|
| C. Peterson
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5064
|
| L. Hayden
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5065
|
| M. Lebert
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5066
|
| M. cohn
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5067
|
| V. Korn
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5068
|
| A. Eberle
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5069
|
| M. A. Palladine
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5070
|
| S. Haung
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5071
|
| M. Geissman
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5072
|
| S. Mitchell
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5073
|
| J. Fassett
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5074
|
| C. Mckenna
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5075
|
| C. Dye
|
| Vol #:
|
| 170
|
|
| | | | | | | |
| |
|
|
| EMC 5076
|
| K. Dalenberg
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5077
|
| C. Snyder
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5078
|
| M. Barber
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5079
|
| R. Sminkey
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5080
|
| G. Frazier
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5081
|
| J. Fuller
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5082
|
| M. Jarred
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5083
|
| A. Joyce
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5084
|
| Z. Alam
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5085
|
| K. Drache
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5086
|
| N. Sheffer
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5087
|
| E. O'Donohoe
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5088
|
| J. Wolfe
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5089
|
| S. Khammoungkhoune
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5090
|
| K. Hereld
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5091
|
| K.Biondi
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5092
|
| D. Barkman
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5093
|
| C. Kimbrough
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5094
|
| K. Cook
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5095
|
| J. Barone
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5096
|
| R. Hirschboeck
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5097
|
| C. Dorn
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5098
|
| C. Pivik
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5099
|
| K. Reynard
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5100
|
| P. Conley
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5101
|
| K. Weidner
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5102
|
| J. Ziffer
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5103
|
| K. Parson
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5104
|
| L. W. Boyd
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5105
|
| J. Ross
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5106
|
| L. Boley
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5107
|
| J. Glasscock
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5108
|
| C. Lin
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5109
|
| M. Bedinger
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5110
|
| Antonia T.
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5111
|
| J. Niksic
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5112
|
| J. Long
|
| Vol #:
|
| 170
|
|
| | | | | | | |
| |
|
|
| EMC 5113
|
| L. Smolin
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5114
|
| W. W. Atkins
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5115
|
| A. Christiansen
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5116
|
| D. W. Tarah
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5117
|
| B. Cook
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5118
|
| J. Silverstein
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5119
|
| J. Wilson
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5120
|
| B. Caton
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5121
|
| J. Otter
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5122
|
| P. Taylor
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5123
|
| J. Solis
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5124
|
| J. Solis
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5125
|
| A. Mrsich
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5126
|
| P. Menyuk
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5127
|
| M. Kahn
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5128
|
| J. Peress
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5129
|
| C. Kenyon
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5130
|
| D. Monticone
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5131
|
| N. Youngberg
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5132
|
| A. Cohen
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5133
|
| D. Slampyak
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5134
|
| S. G. Blandin
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5135
|
| K. Bennett
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5136
|
| A. Bloch
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5137
|
| J. Krein
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5138
|
| B. Tomin
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5139
|
| P. B. Isle
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5140
|
| M. Marlowe
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5141
|
| K. Gisle
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5142
|
| S. Lagree
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5143
|
| L. Forrest
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5144
|
| P. Blair
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5145
|
| J. A. Buikema
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5146
|
| L. Stephhhens
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5147
|
| E. Yoder
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5148
|
| J. Gustafson
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5149
|
| A. Ditmore
|
| Vol #:
|
| 170
|
|
| | | | | | | |
| |
|
|
| EMC 5150
|
| L. A. Aspra
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5151
|
| G. Segreto
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5152
|
| B. Stella
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5153
|
| J. Podgorski
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5154
|
| K. E. Tate
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5155
|
| A. Ahmad
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5156
|
| B. Bryant
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5157
|
| L. Cottle
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5158
|
| M. Jansen
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5159
|
| L. A. Ostro
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5160
|
| Annette & Mort Libnic & Levine
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5161
|
| C. Kroon
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5162
|
| B. Smith
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5163
|
| H. Burns
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5164
|
| M. Roberts
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5165
|
| J. Parkinson
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5166
|
| C. Rodgers
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5167
|
| C.Fraser
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5168
|
| V. Frank
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5169
|
| S. Collins
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5170
|
| K. Cole
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5171
|
| W. Buehlman
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5172
|
| T. Freeman
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5173
|
| P. McCoy
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5174
|
| S. DeMasi
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5175
|
| D. Kipnis
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5176
|
| B. Howard
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5177
|
| L. Hirokane
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5178
|
| J. Mahnoney
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5179
|
| K. Moss
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5180
|
| R. Wolfe
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5181
|
| D. Massie
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5182
|
| D. R. Hoffman
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5183
|
| C. Sukernek
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5184
|
| H. Sobocinski
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5185
|
| E. Verdugo
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5186
|
| T. Kallay
|
| Vol #:
|
| 170
|
|
| | | | | | | |
| |
|
|
| EMC 5187
|
| F. Douglas
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5188
|
| M. Greenway
|
| Vol #:
|
| 170
|
|
| |
|
| EMC 5189
|
| F. Samuelson
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5190
|
| S. Horwich
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5191
|
| M. Wichita
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5192
|
| Y.Ramos
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5193
|
| R. Mansfield
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5194
|
| L. Cole
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5195
|
| S. Corey
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5196
|
| G. Maryash
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5197
|
| D.Lowrie
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5198
|
| N. Abildgaard
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5199
|
| W. Perry
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5200
|
| M. Valdini
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5201
|
| D. Poppe
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5202
|
| D. L. Powers
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5203
|
| E. Meade
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5204
|
| C. Mettling
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5205
|
| H. Gray
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5206
|
| K. Reopell
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5207
|
| B. J. Buchanan
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5208
|
| M. Peltier
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5209
|
| A. Kennedy
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5210
|
| S. Nelson
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5211
|
| E. H. Voyles
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5212
|
| N. Slagle
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5213
|
| H. Dance
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5214
|
| J. Vinal
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5215
|
| F. Schroeder
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5216
|
| F. X. Kleshinski
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5217
|
| T. Voet
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5218
|
| J. M. Powers
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5219
|
| T. H. Birchall
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5220
|
| L. Doherty
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5221
|
| W. A. Freeto
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5222
|
| J. Najjoum
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5223
|
| S. J. Giammona
|
| Vol #:
|
| 170
|
|
| | | | | | | | |
| |
|
|
| EMC 5224
|
| E. Weber
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5225
|
| N. Lopez
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5226
|
| L. Siegel
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5227
|
| A. Taylor
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5228
|
| C. McCroskey
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5229
|
| K. Hamberg
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5230
|
| L. Freeman
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5231
|
| A. Campbell
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5232
|
| T. Baugher
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5233
|
| K. Cullen
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5234
|
| J. Wilhelm
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5235
|
| G. Preuss
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5236
|
| K. Cross
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5237
|
| K. Gowing
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5238
|
| E. Moss
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5239
|
| W. A. McLaughlin
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5240
|
| A. Small
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5241
|
| J. Ertel
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5242
|
| J. Wallace
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5243
|
| V. Valle
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5244
|
| M. L. Bretthauer
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5245
|
| M. De Jesus
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5246
|
| H. Orr
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5247
|
| B. Rodgers
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5248
|
| D. Pilch
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5249
|
| J. Brown
|
| Vol #:
|
| 170
|
| |
|
|
| EMC 5250
|
| K. Humphrey
|
| Vol #:
|
| 170
|
| |
|
|
| 2004D-0082
|
| Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection Systems; Availability
|
| |
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
| |
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0101
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents; and Requiremen
|
|
|
|
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0044
|
| de nova Classification of Factor V Leiden Kit
|
| |
|
|
| NFR
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
