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| Dockets Entered
On March 14, 2005
Table of Contents
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| Docket #
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| Title
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| 1976N-0324
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| Medical Devices
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| 1993D-0394
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| Validation of Blood Establishment Computer Systems
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| 2004D-0484
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| Guidance for Industry on the Role of HIV Drug Resistance Testing in Antiretroviral Drug Development
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| 2004M-0450
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| P040029 - JSZ Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear
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| 2004M-0467
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| P030032/S001 - Hylaform Plus, Approved 10/13/04
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| 2004M-0471
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| Syncardia Systems, Inc., Premarket Approval for Syncardia Temporary CardioWest Total Artificial Heart (TAH-t
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| 2004M-0495
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| P020021 - Wizard X-Cell Photodynamic Therapy Balloon with Fiber Optic Diffuser, Approved 8/1/03
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| 2004M-0496
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| P040022 - EVS Vascular Closure System, Approved 11/3/04
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| 2004M-0497
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| P030031 - Biosense Webster NaviStar/Celsius ThermoCool Diagnostic/Ablation Deflectable Tip Catheters, Approved 11/5/04
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| 2004M-0533
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| P040002 - Endologix PowerLink System
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| 2004M-0538
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| Premarket Approval for Bayer Diagnostics Bayer Versant HCV RNA 3.0 Assay (bDNA)
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| 2004N-0458
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| Dietary Supplements; Regulatory Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994
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| 2004P-0171
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| Standards for 'Similarity' or 'Sameness' of Biotechnology-Derived Products
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| 2005D-0019
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| Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Pri
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| 2005D-0068
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| Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping System
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| 2005D-0069
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| Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems
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| 2005D-0101
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| Guidance: Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Asociated Delivery System
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| 2005N-0017
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| Medical Devices; Hematology and Pathology Devices; Reclassification from Class III to Class II of Automated Blood Cell Separator Device Operating by Centrifugal Separation Principle
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| 2005N-0038
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| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
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| 2005N-0067
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| Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Drug Metabolizing Enzyme Genotyping System
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| 2005N-0071
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| Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Instrumentation for Clinical Multiplex Test Systems
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| 2005N-0075
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| Development of a Web-Based System for Obtaining a User Fee Payment Identification Number and Prescription Drug User Fee Cover Sheet (FDA Form 3397)
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| 1976N-0324
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| Medical Devices
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| ANS 10
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| HFC-20 to Washington University
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| Vol #:
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| 4
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| 1993D-0394
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| Validation of Blood Establishment Computer Systems
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
15607
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| Nutronix International
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| Vol #:
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| 137
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| LET
15608
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| Nutronix International
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| Vol #:
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| 137
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| LET
15609
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| Nutronix International
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| Vol #:
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| 137
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| LET
15610
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| Nutronix International
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| Vol #:
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| 137
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| LET
15611
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| Nutronix International
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| Vol #:
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| 137
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| LET
15612
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| Nutronix International
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| Vol #:
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| 137
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| LET
15613
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| Enzymatic Therapy
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| Vol #:
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| 137
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| LET
15614
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| Enzymatic Therapy
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| Vol #:
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| 137
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| LET
15615
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| Enzymatic Therapy
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| Vol #:
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| 137
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| LET
15616
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| Enzymatic Therapy
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| Vol #:
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| 137
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| LET
15617
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| Enzymatic Therapy
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| Vol #:
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| 137
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| LET
15618
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| Enzymatic Therapy
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| Vol #:
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| 137
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| LET
15619
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| Enzymatic Therapy
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| Vol #:
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| 137
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| LET
15620
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| Your Vitamins Andrew Lessman
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| Vol #:
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| 137
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| LET
15621
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| Your Vitamins Andrew Lessman
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| Vol #:
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| 137
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| LET
15622
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| NBTY Inc.
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| Vol #:
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| 137
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| LET
15623
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| NBTY Inc.
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| Vol #:
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| 137
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| LET
15624
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| North American Pharmacal, Inc.
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| Vol #:
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| 137
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| LET
15625
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| North American Pharmacal Inc.
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| Vol #:
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| 138
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| LET
15626
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| North American Pharmacal Inc.
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| Vol #:
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| 138
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| LET
15627
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| North American Pharmacal, Inc.
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| Vol #:
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| 138
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| LET
15628
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| NBTY Inc.
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| Vol #:
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| 138
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| LET
15629
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| NBTY Inc.
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| Vol #:
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| 138
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| LET
15630
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| NBTY Inc.
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| Vol #:
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| 138
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| LET
15631
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| NBTY Inc.
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| Vol #:
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| 138
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| LET
15632
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| Market America, Inc.
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| Vol #:
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| 138
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| LET
15633
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| Nature's Way Products, Inc.
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| Vol #:
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| 138
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| LET
15634
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| Enzymatic Therapy
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| Vol #:
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| 138
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| LET
15635
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| Source Naturals
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| Vol #:
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| 138
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| LET
15636
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| Nature's Answer
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| Vol #:
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| 138
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| LET
15637
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| Botanical Laboratories, Inc.
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| Vol #:
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| 138
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| LET
15638
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| Botanical Laboratories, Inc.
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| Vol #:
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| 138
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| LET
15639
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| Alliance Marketing Systems, Inc.
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| Vol #:
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| 138
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| LET
15640
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| Advocare International, L.P.
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| Vol #:
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| 138
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| LET
15641
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| Advocare International, L.P.
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| Vol #:
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| 138
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| LET
15642
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| NBTY Inc.
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| Vol #:
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| 138
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| LET
15643
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| NBTY Inc.
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| Vol #:
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| 138
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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|
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|
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| C
10
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| Land O Lakes Feed
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| Vol #:
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| 4
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| EAPE 12
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| Kelsey, Michael
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| Vol #:
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| 4
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| EAPE 13
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| Reynolds, Scott
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| Vol #:
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| 4
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| EAPE 14
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| Johannes, Kenneth
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| Vol #:
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| 4
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| EAPE 15
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| Harris, Sue
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| Vol #:
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| 4
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| EMC 6
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| B Sachau
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| Vol #:
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| 4
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| EMC
7
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| National Grain and Feed Association, Pet Food Institute
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| Vol #:
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| 4
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| 2004D-0484
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| Guidance for Industry on the Role of HIV Drug Resistance Testing in Antiretroviral Drug Development
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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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|
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| 2004M-0450
|
| P040029 - JSZ Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear
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|
|
|
|
| NAD
1
|
| FDA
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| Vol #:
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| 1
|
|
|
|
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| 2004M-0467
|
| P030032/S001 - Hylaform Plus, Approved 10/13/04
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|
|
|
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| NAD
1
|
| FDA
|
| Vol #:
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| 1
|
|
|
|
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| 2004M-0471
|
| Syncardia Systems, Inc., Premarket Approval for Syncardia Temporary CardioWest Total Artificial Heart (TAH-t
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|
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| NAD
1
|
| FDA
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| Vol #:
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| 1
|
|
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| 2004M-0495
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| P020021 - Wizard X-Cell Photodynamic Therapy Balloon with Fiber Optic Diffuser, Approved 8/1/03
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|
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|
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| NAD
1
|
| FDA
|
| Vol #:
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| 1
|
|
|
|
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| 2004M-0496
|
| P040022 - EVS Vascular Closure System, Approved 11/3/04
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|
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004M-0497
|
| P030031 - Biosense Webster NaviStar/Celsius ThermoCool Diagnostic/Ablation Deflectable Tip Catheters, Approved 11/5/04
|
|
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
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| 1
|
|
|
|
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| 2004M-0533
|
| P040002 - Endologix PowerLink System
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|
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
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| 1
|
|
|
|
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| 2004M-0538
|
| Premarket Approval for Bayer Diagnostics Bayer Versant HCV RNA 3.0 Assay (bDNA)
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|
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|
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| NAD
1
|
| FDA
|
| Vol #:
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| 1
|
|
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| 2004N-0458
|
| Dietary Supplements; Regulatory Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994
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|
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|
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| EC 38
|
| Ms. Florence Andrews
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| Vol #:
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| 1
|
|
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| 2004P-0171
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| Standards for 'Similarity' or 'Sameness' of Biotechnology-Derived Products
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|
|
|
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| EMC
4
|
| Genentech Inc
|
| Vol #:
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| 2
|
|
|
|
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| 2005D-0019
|
| Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Pri
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| BKG
1
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| Refs 1 - 6 found in 70FR11990
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| Vol #:
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| 1
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| GDL
1
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| Guidance
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| Vol #:
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| 1
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| | | | | | | | |
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| NAD
1
|
| FDA
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| Vol #:
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| 1
|
|
|
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| 2005D-0068
|
| Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping System
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|
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| GDL
1
|
| Guidance
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| 2005D-0069
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| Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems
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| GDL
1
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| Guidance
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
|
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| 2005D-0101
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| Guidance: Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Asociated Delivery System
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| C
1
Attachment
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| University of Southern CA & Institute ofr Magnetic Resonance Safety, Education and Research
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| Vol #:
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| 1
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| GDL
1
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| Guidance (Level 2)
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| Vol #:
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| 1
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| 2005N-0017
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| Medical Devices; Hematology and Pathology Devices; Reclassification from Class III to Class II of Automated Blood Cell Separator Device Operating by Centrifugal Separation Principle
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| BKG
1
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| Ref 1 found in 70FR11887
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| Vol #:
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| 1
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| NPR
1
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| FDA
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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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| APE 8
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| Bayer HealthCare Pharmaceuticals
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| Vol #:
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| 2
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| EC
7
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| St. Francis Healthcare Adult Oncology IREB
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| Vol #:
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| 2
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| 2005N-0067
|
| Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Drug Metabolizing Enzyme Genotyping System
|
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|
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| NFR
1
|
| FDA
|
| Vol #:
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| 1
|
|
|
|
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| 2005N-0071
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| Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Instrumentation for Clinical Multiplex Test Systems
|
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|
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| NFR
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
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| 2005N-0075
|
| Development of a Web-Based System for Obtaining a User Fee Payment Identification Number and Prescription Drug User Fee Cover Sheet (FDA Form 3397)
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|
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|
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| NAD
1
|
| FDA
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| Vol #:
|
| 1
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|
