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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
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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