510(k) K213612 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
SYLFIRM X
| Applicant | VIOL Co., Ltd., Seongnam-Si, KR |
| Decision | Substantially Equivalent, Jun 23, 2022 |
| Received | Nov 15, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213612
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.