510(k) K082325 ยท EKX Handpiece, Direct Drive, Ac-Powered
APEXUM ABLATOR
| Applicant | Apexum , Ltd., Or Yehuda, IL |
| Decision | Substantially Equivalent, Apr 21, 2009 |
| Received | Aug 14, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082325
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.