510(k) K173676 ยท GEX Powered Laser Surgical Instrument
A-FIT
| Applicant | Hironic Co., Ltd., Gyeonggi-Do, KR |
| Decision | Substantially Equivalent, Sep 14, 2018 |
| Received | Nov 30, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173676
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.