510(k) K990628 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
GYRUS ENDOUROLOGY SYSTEM
| Applicant | Gyrus Medical , Ltd., Cardiff, Wales, GB |
| Decision | Substantially Equivalent, Jun 29, 1999 |
| Received | Feb 25, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990628
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.