510(k) K180224 ยท GEX Powered Laser Surgical Instrument
ELEMENT-TL
| Applicant | Elemenic Co., Ltd., Bucheon-Si, KR |
| Decision | Substantially Equivalent, Mar 15, 2018 |
| Received | Jan 26, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180224
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.