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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 vaginal hydrogel packing system
De Novo Number DEN220052
Device Name BrachyGel Vaginal Hydrogel Packing System
Requester
brachyfoam, inc. d/b/a advaray
722 preston ave. suite 108
charlottesville,  VA  22903
Contact timothy showalter, md, mph
Regulation Number892.5735
Classification Product Code
QXR  
Date Received08/25/2022
Decision Date 08/22/2023
Decision granted (DENG)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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