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De Novo DEN160030
- Device
- Oculeve Intranasal Tear Neurostimulator Device
- Contact
- andy doraiswamy
- De Novo number
- DEN160030
- Product code
- PQJ
- Regulation
- 886.5300
- Classification name
- intranasal electrostimulation device
- Decision
- granted (DENG)
- Decision date
- 2017-04-24
- Date received
- 2016-07-07
- Classification advisory
- Ophthalmic
- Review advisory
- Ophthalmic
- Type
- Direct
Current FDA Classification#
- Product code
- PQJ
- Device name
- Intranasal Electrostimulation Device
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation
- 886.5300
- Implant
- N
- Life sustain/support
- N