510(k) K913109 ยท GEX Powered Laser Surgical Instrument
LATERALASE(TM) CATHETER WITH THERMAL FEEDBACK
| Applicant | Trimedyne, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Oct 8, 1991 |
| Received | Jul 12, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913109
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.