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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 Number
878.4452
Classification Product Code
PGZ
Date Received
01/30/2013
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
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