510(k) K183199 ยท GEX Powered Laser Surgical Instrument
TRIO Handpiece
| Applicant | Omniguide, Inc., Lexington MA, US |
| Decision | Substantially Equivalent, May 2, 2019 |
| Received | Nov 19, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183199
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.