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2006D-0363:
Guidance for Industry and Food and Drug Administration Staff; Draft
Class II Special Controls Guidance Document: Absorbable Hemostatic
Device
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| Document #
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| Received Date
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| Filed
Date
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| Submitter Code
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| Submitter
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| FR
Date
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| FR
Page
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| Comment Date
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| Files
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| Remarks
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| NAD1
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| 10/30/2006
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| FDA
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| FDA
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| 10/31/2006
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| 63774-63775
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| 01/29/2007
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| htm
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| Signature:
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| Linda S. Kahan
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| GDL1
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| 10/30/2006
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| 10/30/2006
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| Federal Government
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| Guidance
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| pdf
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| Signature:
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| Guidance
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| EXT1
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| 12/21/2006
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| 12/21/2006
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| Private Industry
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| Ethicon, Inc.
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| pdf
Attachment
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| CF 2006N-0362/EXT2
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| Signature:
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| Jeffrey N. Gibbs
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| EC1
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| 01/29/2007
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| 01/26/2007
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| Device Industry
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| Kensey Nash Corporation
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| htm
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| Signature:
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| Fatzinger, Robin
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| EC2
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| 01/29/2007
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| 01/28/2007
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| Academia
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| Duke University
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| htm
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| Signature:
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| Lawson, Jeffrey
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| C1
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| 01/29/2007
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| 01/26/2007
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| Health Care Association
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| St. Jude Medical (SJM)
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| pdf
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| Signature:
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| David H. Mueller
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| C2
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| 01/29/2007
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| 01/26/2007
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| Device Industry
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| Ferrosan A/S, Sydmarken
5, DK-2860 Soeborg
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| pdf
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| Signature:
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| Mark E. DuVal
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| C3
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| 01/29/2007
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| 01/29/2007
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| Academia
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| Duke University Medical
Center
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| pdf
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| Signature:
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| Jeffrey H. Lawson, M.D., PhD
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| C4
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| 01/29/2007
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| 01/29/2007
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| Device Industry
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| Ethicon, Inc. (Ethicon)
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| pdf
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| Signature:
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| Jeffrey N. Gibbs
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| EC3
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| 01/30/2007
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| 01/29/2007
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| Device Industry
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| Vascular Solutions
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| pdf
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| Signature:
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| Neymark, Deborah
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| EC4
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| 01/30/2007
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| 01/29/2007
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| Drug Industry
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| Pfizer
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| pdf
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| Signature:
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| Boylan-Bost, Mary
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| NEC1
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| 05/07/2007
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| FDA
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| FDA
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| 05/08/2007
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| 26134-26135
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| 06/07/2007
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| txt
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| Signature:
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| Jeffrey Shuren
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| C5
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| 06/06/2007
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| 06/06/2007
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| Private Industry
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| HemCon Medical Technologies
Inc (HemCon)
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| pdf
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| Signature:
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| Carol A Pratt PhD
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| C6
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| 06/06/2007
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| 06/06/2007
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| Private Industry
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| HemCon Medical Technologies
Inc (HemCon)
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| pdf
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| Signature:
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| John W MOrgan
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| C7
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| 06/07/2007
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| 06/07/2007
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| Private Industry
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| Ethicon Inc
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| pdf
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| Signature:
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| Jeffrey N Gibbs
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| C8
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| 06/06/2007
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| 06/05/2007
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| International Industry
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| Ferrosan A/S
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| pdf
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| Signature:
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| Mark E DuVal
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Top
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Page last updated:
July 24, 2007
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