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| Dockets Entered
On November 1, 2005
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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| 1999P-0033
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| Combat the spread of transmissible spongiform encephalopathy
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 2000P-1491
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| Amend Definition & Standard of Identy for Parmesan Cheese
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2003P-0132
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| Part 135 FDA regulations standard of identity frozen dessert
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| 2005D-0261
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| Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry
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| 2005D-0385
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| Guidance for Industry on Using Electronic Means to Distribute Certain Product Information
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| 2005D-0412
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| Guidance for Industry: A Notice from the Food and Drug Administration to Growers, Food Manufacturers, Food Warehouse Managers, and Transporters of Food Products on Decontamination of Transport Vehicle
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| 2005M-0435
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| P960040/S028 - VENTAK PRIZM AVT System, Approved 3/27/03
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| 2005N-0311
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| Critical Path Initiative; Developing Prevention Therapies; Planning of Workshop
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| 2005N-0404
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| Solicitation of Public Review and Comment on Research Protocol:
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| 2005N-0426
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of Participation
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| 2005P-0267
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| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
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| 2005P-0323
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| Immediately remove Adderall and Adderall XR from the market for safety reasons
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| 2005P-0436
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| ADA 21-863' Ibuprogen Liquid filled gelatin capsules 200 mg; Ranbaxy Laboratories, Ltd.
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| 2005P-0440
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| To deny approval of Smith & Nephew's premarket approval application (PMA) for the Birmingham hip resurfacing system (P040033) based on the data currently submitted in support of the PMA
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
16709
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| DMD Pharmaceuticals
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| Vol #:
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| 150
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| LET
16710
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| WTSmed
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| Vol #:
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| 150
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| LET
16711
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| Mediainfo
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| Vol #:
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| 150
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| LET
16712
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| ProCaps Laboratories
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| Vol #:
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| 150
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| LET
16713
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| Nutramax Laboratories, Inc.
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| Vol #:
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| 150
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| LET
16714
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| Herbalist Alchemist
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| Vol #:
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| 150
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| LET
16715
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| Cadbury Adams USA LLC
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| Vol #:
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| 150
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| LET
16716
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| Caudill Seed Company
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| Vol #:
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| 150
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| LET
16717
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| Nature's Way Products, Inc.
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| Vol #:
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| 150
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| | | | | | | | |
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| EMC 2
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| J. Deni, II
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| Vol #:
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| 1
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| MO 13
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| Ecumed Health Group, Amador Reyes, Juan Carrai and Richard Stone, M.D.
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| Vol #:
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| 2
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| 2005D-0261
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| Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry
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| EMC
3
Attachment
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| Blood Systems, Inc.
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| Vol #:
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| 2
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| 2005D-0385
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| Guidance for Industry on Using Electronic Means to Distribute Certain Product Information
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| EC
2
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| FDAReady Consulting
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| Vol #:
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| 1
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| 2005D-0412
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| Guidance for Industry: A Notice from the Food and Drug Administration to Growers, Food Manufacturers, Food Warehouse Managers, and Transporters of Food Products on Decontamination of Transport Vehicle
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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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| 2005M-0435
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| P960040/S028 - VENTAK PRIZM AVT System, Approved 3/27/03
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| AAV
1
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| Guidant CRM Corporation
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| Vol #:
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| 1
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| 2005N-0311
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| Critical Path Initiative; Developing Prevention Therapies; Planning of Workshop
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| EC
1
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| American Society of Clinical Oncology
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| Vol #:
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| 1
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| EC
2
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| Pfizer
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| Vol #:
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| 1
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| EC
3
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| American Society of Clinical Oncology
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| Vol #:
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| 1
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| EC
4
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| AstraZeneca
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| Vol #:
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| 1
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| EC
5
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| Amer Soc for Clinical Pharmacology & Therapeutics
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| Vol #:
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| 1
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| EC
2205
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| Mr. David Benfell
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| Vol #:
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| 32
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| EMC 217
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| C. Rubin
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| Vol #:
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| 3
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| EMC 218
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| B. Sanders
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| Vol #:
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| 3
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| EMC 219
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| A. Hicka
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| Vol #:
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| 3
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| EMC 220
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| D. King
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| Vol #:
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| 3
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| EMC 221
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| M. Rich
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| Vol #:
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| 4
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| EMC 222
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| A. Bruce
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| Vol #:
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| 3
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| EMC 223
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| V. Richards
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| Vol #:
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| 3
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| EMC 224
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| S. Staley
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| Vol #:
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| 3
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| EMC 225
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| No signature
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| Vol #:
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| 3
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| EMC 226
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| S. Manewith
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| Vol #:
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| 3
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| EMC 227
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| E. Feldman, MD
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| Vol #:
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| 3
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