The following data is part of a premarket notification filed by Gentex Corporation with the FDA for The Lens Or Ommi-gard.
| Device ID | K800521 |
| 510k Number | K800521 |
| Device Name: | THE LENS OR OMMI-GARD |
| Classification | Lens, Spectacle, Non-custom (prescription) |
| Applicant | GENTEX CORPORATION 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HQG |
| CFR Regulation Number | 886.5844 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-03-06 |
| Decision Date | 1980-03-12 |