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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 prostate immobilizer rectal balloon
De Novo Number DEN130036
510(K) Number K132194
Device Name PROSTATE IMMOBILIZER RECTAL BALLOON
Requester
radiadyne
901 new york avenue, nw
washington,  DC  20001
Contact mark a heller
Regulation Number892.5720
Classification Product Code
PCT  
Date Received07/15/2013
Decision Date 01/28/2014
Decision granted (DENG)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
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