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2007D-0201: Guidance for Industry and Food and Drug Administration Staff; Premarket Notification (510(k)) Submissions for Medical Devices That Include Antimicrobial Agents
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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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| 07/18/2007
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| FDA
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| FDA
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| 07/19/2007
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| 39630-39631
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| 10/17/2007
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| pdf
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| Signature:
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| Jeffrey Shuren
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| GDL1
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| 07/19/2007
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| 07/19/2007
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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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| EC1
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| 08/16/2007
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| 08/11/2007
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| Device
Association
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| Surgical migraine
clinic
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| Signature:
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| Sultaneh, Ali
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| EC2
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| 09/17/2007
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| 08/31/2007
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| Individual
Consumer
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| Mr. gregory
pinchinat
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| Signature:
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| pinchinat, gregory
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| C1
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| 10/15/2007
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| 10/15/2007
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| Private
Industry
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| Enturia, Inc.
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| pdf
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| Signature:
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| Linda McBride
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| C2
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| 10/17/2007
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| 10/17/2007
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| Private
Industry
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| BECKER &
ASSOCIATES
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| pdf
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| Signature:
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| Philip J. Phillips
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| EC3
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| 10/17/2007
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| 10/15/2007
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| Device Industry
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| Zimmer, Inc.
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| htm
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| Signature:
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| Hipsher, Brandon
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| EC4
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| 10/17/2007
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| 10/16/2007
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| Device Industry
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| Ms. Michelle
Gudith
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| htm
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| Signature:
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| Gudith, Michelle
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| EC5
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| 10/17/2007
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| 10/16/2007
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| Device
Association
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| Advanced Medical
Technology Association
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| htm
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| Signature:
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| Dempsey, Ruey
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| EC6
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| 10/18/2007
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| 10/17/2007
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| Academia
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| Center for Biofilm
Engineering, Montana St. Univ.
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| htm
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| Signature:
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| Sturman, Paul
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| EC7
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| 10/18/2007
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| 10/17/2007
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| Device Industry
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| Cook Group
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| htm
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| Signature:
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| Heise, Theodore
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| EC8
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| 10/18/2007
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| 10/17/2007
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| Private
Industry
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| Milliken
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| htm
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| Signature:
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| Mateus, Carolina
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| EC9
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| 10/18/2007
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| 10/17/2007
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| Device Industry
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| Covidien
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| htm
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| Signature:
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| Palmer Berns, Tracy
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| C3
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| 10/18/2007
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| 10/18/2007
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| Private
Industry
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| AdvaMed
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| pdf
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| Signature:
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| Ruey C. Dempsey
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| C4
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| 10/23/2007
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| 10/23/2007
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| Private
Industry
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| American
Academy of Orthopadic Surgeons (AAOS)
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| pdf
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| Signature:
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| James H. Beaty
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| C5
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| 10/19/2007
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| 10/19/2007
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| Private
Industry
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| ENVIRONMENTAL RESEARCH
CENTER
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| pdf
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| Signature:
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| George E. Pierce
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| C6
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| 10/25/2007
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| 10/25/2007
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| Device Industry
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| Arrow
International
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| pdf
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| Signature:
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| Chuck Morreale
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Top | Up
Page last updated:
January 4, 2008
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