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De Novo DEN170086
- Device
- TrueTear Intranasal Tear Neurostimulator
- Contact
- nooshin azizi
- De Novo number
- DEN170086
- Product code
- QBR
- Regulation
- 886.5310
- Classification name
- intranasal electrostimulation device for dry eye symptoms
- Decision
- granted (DENG)
- Decision date
- 2018-05-17
- Date received
- 2017-10-23
- Classification advisory
- Ophthalmic
- Review advisory
- Ophthalmic
- Type
- Direct
Current FDA Classification#
- Product code
- QBR
- Device name
- Intranasal Electrostimulation Device For Dry Eye Symptoms
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation
- 886.5310
- Implant
- N
- Life sustain/support
- N