510(k) K203054 ยท GEX Powered Laser Surgical Instrument
FlexSys
| Applicant | Gme German Medical Engineering GmbH, Erlangen, DE |
| Decision | Substantially Equivalent, Mar 5, 2021 |
| Received | Oct 7, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203054
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.