510(k) K971648 ยท GEX Powered Laser Surgical Instrument
SHARPLAN ERBIUM: YAG LASER (4020)
| Applicant | Sharplan Lasers, Inc., Warwick RI, US |
| Decision | Substantially Equivalent, Jul 23, 1997 |
| Received | May 5, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971648
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.