510(k) K112442 ยท GEX Powered Laser Surgical Instrument
RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM
| Applicant | Biolitec Medical Devices, Inc., Grandville MA, US |
| Decision | Substantially Equivalent, Sep 30, 2011 |
| Received | Aug 24, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112442
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.