Skip to contentDe Novo DEN200063
- Device
- Kerasave
- Contact
- mauro beccaro
- De Novo number
- DEN200063
- Product code
- QCW
- Regulation
- 886.4320
- Classification name
- corneal storage media with preservatives including anti-fungal
- Decision
- granted (DENG)
- Decision date
- 2022-05-02
- Date received
- 2020-10-01
- Classification advisory
- Ophthalmic
- Review advisory
- Ophthalmic
- Type
- Post-NSE
Current FDA Classification#
- Product code
- QCW
- Device name
- Corneal Storage Media With Preservatives Including Anti-Fungal
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation
- 886.4320
- Implant
- N
- Life sustain/support
- N