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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 wound retraction and protection system
De Novo Number DEN150038
Device Name CleanCisionTM Wound Retraction and Protection System
Requester
prescient surgical
1585 industrial rd.
san carlos,  CA  94070
Contact lisa ruehlow
Regulation Number878.4371
Classification Product Code
PQI  
Date Received08/13/2015
Decision Date 12/16/2016
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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