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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 ocular pattern recorder
De Novo Number DEN140017
Device Name SENSIMED TRIGGERFISH
Requester
sensimed ag
16 appleton street
waltham,  MA  02453
Contact marcy moore
Regulation Number886.1925
Classification Product Code
PLZ  
Date Received05/06/2014
Decision Date 03/04/2016
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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