510(k) K954597 ยท GEX Powered Laser Surgical Instrument
RIGHT ANGLE LASER FIBERS
| Applicant | Trimedyne, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Mar 11, 1996 |
| Received | Oct 3, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954597
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.