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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 dynamic rectal control system
De Novo Number DEN140020
Device Name ECLIPSE SYSTEM
Requester
pelvalon
1171 barroilhet drive
hillsborough,  CA  94010
Contact cindy domecus
Regulation Number876.5930
Classification Product Code
PJH  
Date Received06/24/2014
Decision Date 02/12/2015
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Expedited Review Yes
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