510(k) K223074
- Device
- CorNeat EverPatch
- Applicant
- Corneat Vision , Ltd.
- 510(k) number
- K223074
- Product code
- QWU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-06-02
- Date received
- 2022-09-30
- Regulation
- 886.3130
- Classification name
- Prosthesis, Eyelid Spacer/Graft, Polymer
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Gerry Tal
- Address
- 4 Hasheyzaf St. Raanana IL 4366411 4366411
FDA Registration Numbers#
- 3010155661
- 3006550126