510(k) K080525 ยท GEX Powered Laser Surgical Instrument
COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W
| Applicant | Cook Urological, Inc., Bloomington IN, US |
| Decision | Substantially Equivalent, Apr 17, 2008 |
| Received | Feb 26, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080525
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.