Skip to contentDe Novo DEN200002
- Device
- Tangible Boost
- Contact
- kelly mabry
- De Novo number
- DEN200002
- Product code
- QMM
- Regulation
- 886.5919
- Classification name
- hydrophilic re-coating solution
- Decision
- granted (DENG)
- Decision date
- 2020-09-24
- Date received
- 2020-01-13
- Classification advisory
- Ophthalmic
- Review advisory
- Ophthalmic
- Type
- Direct
Current FDA Classification#
- Product code
- QMM
- Device name
- Hydrophilic Re-Coating Solution
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation
- 886.5919
- Implant
- N
- Life sustain/support
- N