510(k) DEN160030
- Device
- Oculeve Intranasal Tear Neurostimulator Device
- Applicant
- Oculeve, Inc.
- 510(k) number
- DEN160030
- Product code
- PQJ
- Decision
- Unknown (DENG)
- Decision date
- 2017-04-24
- Date received
- 2016-07-07
- Regulation
- 886.5300
- Classification name
- Intranasal Electrostimulation Device
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- ANDY DORAISWAMY
- Address
- 395 Oyster Pt. Blvd. Suite 501 South San Francisco CA US 94080 94080
FDA Registration Numbers#
- 1649518
Source Documents#
510(k) summary PDF not indicated by FDA