510(k) K962632 ยท GEX Powered Laser Surgical Instrument
OMNIPULSE/OMNIPULSE-MAX
| Applicant | Trimedyne, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jan 16, 1997 |
| Received | Jul 5, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962632
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.