510(k) K220794 ยท ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
10PL
| Applicant | Tentech Co. , Ltd., Gangnam-Gu, KR |
| Decision | Substantially Equivalent, Nov 10, 2022 |
| Received | Mar 18, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220794
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.