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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 negative pressure wound therapy device for reduction of wound complications
De Novo Number DEN180013
Device Name PREVENA 125 and PREVENA PLUS 125 Therapy Units
Requester
kci usa, inc.
6203 farinon drive
san antonio,  TX  78249
Contact kimberly mccoy
Regulation Number878.4783
Classification Product Code
QFC  
Date Received03/15/2018
Decision Date 04/19/2019
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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