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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 suture, recombinant technology
De Novo Number DEN060003
510(K) Number K052225
Device Name TEPHAFLEX ABSORBABLE SUTURE
Requester
tepha, inc.
840 memorial drive
cambridge,  MA  02139
Contact mary p legraw
Regulation Number878.4494
Classification Product Code
NWJ  
Date Received05/12/2006
Decision Date 02/08/2007
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Classification Order Classification Order
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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