The following data is part of a De Novo classification by Oculeve, Inc. with the FDA for Oculeve Intranasal Tear Neurostimulator Device.
| DeNovo ID | DEN160030 |
| Device Name: | Oculeve Intranasal Tear Neurostimulator Device |
| Classification | Intranasal Electrostimulation Device |
| Applicant | OCULEVE, INC. 395 Oyster Point Blvd suite 501 South San Francisco, CA 94080 |
| Contact | Andy Doraiswamy |
| Product Code | PQJ |
| CFR Regulation Number | 886.5300 [🔎] |
| 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 | 2016-07-07 |
| Decision Date | 2017-04-24 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850102007205 | DEN160030 | 000 |
| 00850102007199 | DEN160030 | 000 |
| 00850102007182 | DEN160030 | 000 |
| 00850102007175 | DEN160030 | 000 |
| 00850102007168 | DEN160030 | 000 |
| 00850102007151 | DEN160030 | 000 |