The following data is part of a De Novo classification by Tangible Science, Inc. with the FDA for Tangible Boost.
DeNovo ID | DEN200002 |
Device Name: | Tangible Boost |
Classification | Hydrophilic Re-coating Solution |
Applicant | Tangible Science, Inc. 740 Broadway Redwood City, CA 94063 |
Contact | Kelly Mabry |
Product Code | QMM |
CFR Regulation Number | 886.5919 [🔎] |
Decision | Granted (DENG) |
510(k) Premarket Notification | Device 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 Board | Ophthalmic |
Classification Advisory | Ophthalmic |
Type | Direct |
Date Received | 2020-01-13 |
Decision Date | 2020-09-24 |
Reclassification Order: | Reclassification Order |
Device Identifier | submissionNumber | Supplement |
---|---|---|
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 |