510(k) K180406 ยท GEX Powered Laser Surgical Instrument
Ellipse Ydun
| Applicant | Ellipse A/S, Hoersholm, DK |
| Decision | Substantially Equivalent, Mar 15, 2018 |
| Received | Feb 14, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K180406
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.