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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 hydrophilic re-coating solution
De Novo Number DEN200002
Device Name Tangible Boost
Requester
Tangible Science, Inc.
740 broadway
redwood city,  CA  94063
Contact kelly mabry
Regulation Number886.5919
Classification Product Code
QMM  
Date Received01/13/2020
Decision Date 09/24/2020
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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