510(k) K113390 ยท GEX Powered Laser Surgical Instrument
LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500)
| Applicant | Meridian AG, Greenwood Village CO, US |
| Decision | Substantially Equivalent, Feb 14, 2012 |
| Received | Nov 16, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113390
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.