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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 tear duct occluder
De Novo Number DEN140022
Device Name GLAUCOMA COMPANION
Requester
innovatex, inc.
150 buckskin dr.
weston,  MA  02493
Contact stephen c chen
Regulation Number886.5838
Classification Product Code
PLX  
Date Received07/18/2014
Decision Date 04/20/2016
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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