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 |