510(k) K964585 ยท GEX Powered Laser Surgical Instrument
RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE)
| Applicant | Trimedyne, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Apr 17, 1997 |
| Received | Nov 15, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964585
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.