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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 implantable transprostatic tissue retractor system
De Novo Number DEN130023
510(K) Number K130651
Device Name UROLIFT SYSTEM
Requester
neotract, inc.
4473 willow rd.
suite 100
pleasanton,  CA  94588
Contact nancy e isaac
Regulation Number876.5530
Classification Product Code
PEW  
Date Received03/07/2013
Decision Date 09/13/2013
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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