510(k) K213554 ยท GEX Powered Laser Surgical Instrument
Sentient Manufacturing Laser Fiber
| Applicant | Sentient Manufacturing , LLC, Park City UT, US |
| Decision | Substantially Equivalent, Feb 2, 2022 |
| Received | Nov 8, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213554
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.