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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 surgical instrument for improvement in the appearance of cellulite
De Novo Number DEN110004
510(K) Number K101231
Device Name CABOCHON SYSTEM
Requester
cabochon aesthetics, inc.
127 independence dr.
menlo park,  CA  94025
Contact ben brian
Regulation Number878.4790
Classification Product Code
OUP  
Date Received10/31/2011
Decision Date 07/12/2013
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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