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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 temporary, internal use hemostatic
De Novo Number DEN160012
Device Name D2 Dressing
Requester
z-medica, llc
4 fairfield blvd.
wallingford,  CT  06492
Contact sheila k. wallin
Regulation Number878.4454
Classification Product Code
POD  
Date Received03/16/2016
Decision Date 06/30/2017
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
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