510(k) K041660 ยท GEX Powered Laser Surgical Instrument
TRIMEDYNE HOLMIUM LASER SYSTEMS
| Applicant | Trimedyne, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Sep 8, 2004 |
| Received | Jun 18, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041660
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.