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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name cutaneous tissue adhesive with mesh
De Novo Number DEN090005
510(K) Number K082289
Device Name PRINEO SKIN CLOSURE SYSTEM
Requester
closure medical corp.
5250 greens dairy rd.
raleigh,  NC  27616
Contact bruce krattenmaker
Regulation Number878.4011
Classification Product Code
OMD  
Date Received03/24/2009
Decision Date 04/30/2010
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Reclassification Order Reclassification Order
Type Post-NSE
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