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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 urethral insert with pump for bladder drainage
De Novo Number DEN130044
Device Name INFLOW INTRAURETHRAL VALVE-PUMP
Requester
vesiflo, inc.
8672 154th ave ne
redmond,  WA  98052
Contact kevin m connolly
Regulation Number876.5140
Classification Product Code
PIH  
Date Received10/25/2013
Decision Date 10/14/2014
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
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