De Novo DEN140022
- Device
- GLAUCOMA COMPANION
- Contact
- stephen c chen
- De Novo number
- DEN140022
- Product code
- PLX
- Regulation
- 886.5838
- Classification name
- tear duct occluder
- Decision
- granted (DENG)
- Decision date
- 2016-04-20
- Date received
- 2014-07-18
- Classification advisory
- Ophthalmic
- Review advisory
- Ophthalmic
- Type
- Direct
Current FDA Classification#
- Product code
- PLX
- Device name
- Tear Duct Occluder
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation
- 886.5838
- Implant
- N
- Life sustain/support
- N