510(k) K161771 ยท GEX Powered Laser Surgical Instrument
Medilas H Laser Fibers
| Applicant | Dornier Medtech America, Inc., Kennesaw GA, US |
| Decision | Substantially Equivalent, Jul 28, 2016 |
| Received | Jun 28, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161771
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.