510(k) K953794 ยท GEX Powered Laser Surgical Instrument
SHARPLAN LASERS, INC. SURGICAL DIODE LASER
| Applicant | Sharplan Lasers, Inc., Warwick RI, US |
| Decision | Substantially Equivalent, Nov 14, 1995 |
| Received | Aug 14, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953794
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.