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| Dockets Entered
On March 10, 2005
Table of Contents
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| Docket #
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| Title
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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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-0545
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| Nonclinical and Clinical Datasets; Notice of Pilot Project
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| 2005H-0099
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| Civil Money Penalty Complaint in the Matter of Gerald Dorros, M.D.
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| 2005M-0087
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| Premarket Approval for Eastman Kodak Company ( P030007), Kodak Mammography CAD Engine
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| 2005M-0088
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| Premarket Approval for Irvine Biomedical (P040014), IBI Therapy Cardiac Ablation System
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| 2005M-0089
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| P030030 - URYX Urethral Bulking Agent, Approved 12/16/04
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| 2005M-0092
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| P040006 - CHARITE Artificial Disc, Approved 10/26/04
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| 2005N-0036
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| Use of Color on Pharmaceutical Product Labels, Labeling and Packaging; Public Hearing
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| 2005N-0038
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| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| EC 31
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| USMC Retired Flag Officer
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| Vol #:
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| 140
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| EMC 53
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| C Trefts
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| Vol #:
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| 141
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| EMC 54
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| T Trefts
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| Vol #:
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| 141
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| EMC 55
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| Willow
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| Vol #:
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| 141
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| EMC 56
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| L Cleverly
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| Vol #:
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| 141
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| EMC 57
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| J Hailstone
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| Vol #:
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| 141
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| EMC 58
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| T Bowermeister
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| Vol #:
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| 141
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| EMC 59
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| B Cox
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| Vol #:
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| 141
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| EMC 60
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| A concerned citizen
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| Vol #:
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| 141
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| EMC 61
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| T Trefts
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| Vol #:
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| 141
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| EMC 62
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| T Trefts
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| Vol #:
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| 141
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| EMC 63
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| C Thayer
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| Vol #:
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| 141
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| EMC
64
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| Military Vaccine Action Committee LLC
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| Vol #:
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| 141
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| EMC 65
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| M Berg
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| Vol #:
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| 141
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| EMC 66
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| T Jones
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| Vol #:
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| 141
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| EMC 67
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| P Anello
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| Vol #:
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| 141
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| EMC 68
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| C Evans
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| Vol #:
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| 141
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| EMC
69
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| Wyoming Vaccine Information Network
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| Vol #:
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| 141
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| EMC 70
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| M Fitzgerald
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| Vol #:
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| 141
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| EMC 71
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| K Bowers
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| Vol #:
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| 141
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| EMC 72
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| L Fishpaw
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| Vol #:
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| 141
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| EMC 73
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| Lummus
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| Vol #:
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| 141
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| EMC 74
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| L Smith
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| Vol #:
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| 141
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| EMC 75
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| J Hailstone
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| Vol #:
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| 141
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| EMC 76
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| G Black
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| Vol #:
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| 141
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
15568
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| NEXT Sp. zoo
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| Vol #:
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| 137
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| LET
15569
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| CPharmax, Inc.
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| Vol #:
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| 137
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| LET
15570
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| Vital Healthcare Product Corp.
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| Vol #:
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| 137
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| LET
15571
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| Advocare International, L.P.
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| Vol #:
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| 137
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| LET
15572
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| Alert Nutrition, LLC
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| Vol #:
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| 137
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| LET
15573
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| Alert Nutrition, LLC
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| Vol #:
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| 137
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| LET
15574
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| Tianshi Health Products, Inc.
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| Vol #:
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| 137
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| |
|
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| C 96
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| S Stanfield
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| Vol #:
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| 15
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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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| C
4
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| CRA MDR Network
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| Vol #:
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| 1
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| C
5
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| Public Citizen
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| Vol #:
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| 1
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| EMC
1
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| Merck & Co., Inc
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| Vol #:
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| 1
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| 2004N-0545
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| Nonclinical and Clinical Datasets; Notice of Pilot Project
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| EMC
2
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| Merck & Co., Inc
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| Vol #:
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| 1
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| 2005H-0099
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| Civil Money Penalty Complaint in the Matter of Gerald Dorros, M.D.
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| CS
1
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| HFA-305
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| Vol #:
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| 1
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| SET
1
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| HF-3 to Gerald Dorros, M.D.
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| Vol #:
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| 1
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| 2005M-0087
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| Premarket Approval for Eastman Kodak Company ( P030007), Kodak Mammography CAD Engine
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| AAV
1
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| Eastman Kodak Company
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| Vol #:
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| 1
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| 2005M-0088
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| Premarket Approval for Irvine Biomedical (P040014), IBI Therapy Cardiac Ablation System
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| AAV
1
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| Irvine Biomedical
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| Vol #:
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| 1
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| 2005M-0089
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| P030030 - URYX Urethral Bulking Agent, Approved 12/16/04
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| AAV
1
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| Genyx Medical, Inc.
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| Vol #:
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| 1
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| 2005M-0092
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| P040006 - CHARITE Artificial Disc, Approved 10/26/04
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| AAV
1
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| DePuy Spine, Inc.
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| Vol #:
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| 1
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| 2005N-0036
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| Use of Color on Pharmaceutical Product Labels, Labeling and Packaging; Public Hearing
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| EMC 3
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| S Smilek RPh
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| Vol #:
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| 1
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| EMC 4
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| M Winer RPh
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| Vol #:
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| 1
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| 2005N-0038
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| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
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| EMC 1
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| W Heim
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| Vol #:
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| 1
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