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FDA 510(k) Application Details - DEN090005
Device Classification Name
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
OMD
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More FDA Info for this Product Code
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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