510(k) K843957 ยท HRG Engine, Trephine, Accessories, Ac-Powered
ULTRATHIN/SP LENS
| Applicant | Optical Systems Intl., Inc., Hialeah FL, US |
| Decision | Substantially Equivalent, Jul 31, 1985 |
| Received | Oct 10, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K843957
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.