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

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