510(k) K800521 ยท HQG Lens, Spectacle, Non-Custom (Prescription)
THE LENS OR OMMI-GARD
| Applicant | Gentex Corporation, Mchenry IL, US |
| Decision | Substantially Equivalent, Mar 12, 1980 |
| Received | Mar 6, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K800521
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.