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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 powered microneedle device
De Novo Number DEN160029
Device Name SkinPen Precision System
Requester
bellus medical, llc
12001 n. central expwy.
dallas,  TX  75243
Contact jennifer block
Regulation Number878.4430
Classification Product Code
QAI  
Date Received07/05/2016
Decision Date 03/01/2018
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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