FDA 510(k) Application Details - DEN090005

Device Classification Name

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510(K) Number DEN090005
Device Name PRINEO SKIN CLOSURE SYSTEM
Applicant CLOSURE MEDICAL CORP.
5250 GREENS DAIRY RD.
RALEIGH, NC 27616 US
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Contact BRUCE KRATTENMAKER
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Regulation Number

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Classification Product Code OMD
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Date Received 03/24/2009
Decision Date 04/30/2010
Decision DENG -
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type Post-NSE
Reviewed By Third Party N
Expedited Review



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