510(k) K081191 ยท EKX Handpiece, Direct Drive, Ac-Powered
TCM ENDO 20
| Applicant | NOUVAG AG, Gebenstorf, CH |
| Decision | Substantially Equivalent, Aug 7, 2008 |
| Received | Apr 28, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081191
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.