510(k) K960768 ยท GEX Powered Laser Surgical Instrument
LASER FIBER DELIVERY/CLEANING CATHETER
| Applicant | Cook Urological, Inc., Spencer IN, US |
| Decision | Substantially Equivalent, May 14, 1996 |
| Received | Feb 26, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960768
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.