510(k) K122593 ยท FEH Electrode, Flexible Suction Coagulator
PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2
| Applicant | Optim, LLC, Sturbridge MA, US |
| Decision | Substantially Equivalent, Sep 13, 2012 |
| Received | Aug 24, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122593
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.