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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 strabismus detection device
De Novo Number DEN130051
Device Name PEDIATRIC VISION SCANNER
Requester
rebiscan, inc.
30 mount auburn st., suite b
cambridge,  MA  02138
Contact justin g shaka
Regulation Number886.1342
Classification Product Code
PMW  
Date Received12/13/2013
Decision Date 06/08/2016
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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