510(k) K161503 ยท GEX Powered Laser Surgical Instrument
ORION
| Applicant | Yerim Engineering Co., Ltd., Gimpo-Si, KR |
| Decision | Substantially Equivalent, Aug 26, 2016 |
| Received | Jun 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161503
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.