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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 non-absorbable, expandable, hemostatic sponge for temporary internal use
De Novo Number DEN130016
510(K) Number K130218
Device Name XSTAT
Requester
revmedx, inc.
555 13th street nw
washington,  DC  20004
Contact john j smith
Regulation Number878.4452
Classification Product Code
PGZ  
Date Received01/30/2013
Decision Date 04/03/2014
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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