510(k) K954648 ยท HIH Hysteroscope (And Accessories)
FEMRX OPERASTAR SYSTEM
| Applicant | Gynecare Innovation Center, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Mar 14, 1996 |
| Received | Oct 10, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954648
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.