510(k) K854218 ยท HQG Lens, Spectacle, Non-Custom (Prescription)
THE ULTRA-MATE LENS
| Applicant | Optical Systems Intl., Inc., Hialeah FL, US |
| Decision | Substantially Equivalent, Nov 12, 1985 |
| Received | Oct 17, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854218
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.