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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 extracorporeal shock wave device for treatment of diabetic foot ulcers
De Novo Number DEN160037
Device Name dermaPACE System
Requester
sanuwave, inc.
11475 great oaks way, suite 150
alpharetta,  GA  30022
Contact peter stegagno
Regulation Number878.4685
Classification Product Code
PZL  
Date Received07/25/2016
Decision Date 12/28/2017
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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