510(k) K964365 ยท FAS Electrode, Electrosurgical, Active, Urological
RESECTOSCOPE CUTTING LOOP ELECTRODE
| Applicant | Omnitech Systems, Inc., Valparaiso IN, US |
| Decision | Substantially Equivalent, Apr 22, 1997 |
| Received | Nov 1, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964365
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.