Tangible Boost

Hydrophilic Re-coating Solution

Tangible Science, Inc.

The following data is part of a De Novo classification by Tangible Science, Inc. with the FDA for Tangible Boost.

Pre-market Notification Details

DeNovo IDDEN200002
Device Name:Tangible Boost
ClassificationHydrophilic Re-coating Solution
Applicant Tangible Science, Inc. 740 Broadway Redwood City,  CA  94063
ContactKelly Mabry
Product CodeQMM  
CFR Regulation Number886.5919 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardOphthalmic
Classification AdvisoryOphthalmic
TypeDirect
Date Received2020-01-13
Decision Date2020-09-24
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B673FG6 DEN200002 000
B673FG6 DEN200002 000
B673FG6 DEN200002 000
B673FG6 DEN200002 000
B673FG6 DEN200002 000
B673FG6 DEN200002 000
B673FG6 DEN200002 000
B673FG6 DEN200002 000
B673FG6 DEN200002 000
B673FG6 DEN200002 000
B673FG6 DEN200002 000
B673FG6 DEN200002 000
B673FG6 DEN200002 000
B673FG6 DEN200002 000
B673FG6 DEN200002 000

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