510(k) K171443 ยท GEX Powered Laser Surgical Instrument
Etherea MX
| Applicant | Vydence Medical Industria E Comercio Ltda, Ceat - Sao Carlos/Sp Sao Paulo, BR |
| Decision | Substantially Equivalent, Apr 20, 2018 |
| Received | May 16, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171443
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.