510(k) K160227 ยท GEX Powered Laser Surgical Instrument
ACCENTO / HWA Dual/Single laser
| Applicant | Bison Medical Co, Ltd., Geum Cheon Gu, KR |
| Decision | Substantially Equivalent, Apr 22, 2016 |
| Received | Jan 29, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160227
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.