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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 percutaneous surgical set with attachments
De Novo Number DEN110016
510(K) Number K110431
Device Name PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS
Requester
ethicon endo-surgery
4545 creek rd.
cincinnati,  OH  45242
Contact thomas bosticco
Regulation Number878.4805
Classification Product Code
OXT  
Date Received09/21/2011
Decision Date 04/30/2012
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
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