510(k) K131095 ยท GEX Powered Laser Surgical Instrument
DEKA SYNCHRO REPLA: Y FAMILY OF LASER SYSTEMS
| Applicant | El.En Electronic Engineering Spa, Calenzano, IT |
| Decision | Substantially Equivalent, Dec 5, 2013 |
| Received | Apr 18, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131095
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.