510(k) K964892 ยท FJL Resectoscope
FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)
| Applicant | Gynecare Innovation Center, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Feb 4, 1997 |
| Received | Dec 6, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964892
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.