510(k) K132665 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
PELLEVE GLIDESAFE 10MM, 15MM & 20MM HANDPIECE, PELLEVE S5 - IEC
| Applicant | Ellman International, Inc., Hicksville NY, US |
| Decision | Substantially Equivalent, Sep 25, 2013 |
| Received | Aug 27, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132665
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.