510(k) K971305 ยท HIH Hysteroscope (And Accessories)
FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM
| Applicant | Gynecare Innovation Center, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Aug 11, 1997 |
| Received | Apr 8, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971305
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.