510(k) K093451 ยท GEX Powered Laser Surgical Instrument
OMNIGUIDE BEAMPATH CO2 MARK III WAVEGUIDE FIBER WITH LOW PROFILE/LOW LOSS TIP
| Applicant | Omniguide, Inc., Cambridge MA, US |
| Decision | Substantially Equivalent, Nov 20, 2009 |
| Received | Nov 5, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093451
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.