The following data is part of a premarket notification filed by Treace Medical, Inc. with the FDA for Eye Gard.
| Device ID | K872000 |
| 510k Number | K872000 |
| Device Name: | EYE GARD |
| Classification | Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
| Applicant | TREACE MEDICAL, INC. SUITE 400 22 NORTH SECOND STREET Memphis, TN 38103 |
| Contact | Thomas, Jr |
| Correspondent | Thomas, Jr TREACE MEDICAL, INC. SUITE 400 22 NORTH SECOND STREET Memphis, TN 38103 |
| Product Code | HOY |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-26 |
| Decision Date | 1987-07-21 |