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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 oral electronic vision aid
De Novo Number DEN130039
Device Name BRAINPORT V100 DEVICE
Requester
wicab, inc
1835 market street, 29th floor
philadelphia,  PA  19103
Contact steven b datlof
Regulation Number886.5905
Classification Product Code
PIC  
Date Received08/07/2013
Decision Date 06/18/2015
Decision granted (DENG)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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