510(k) K080032 ยท NEA Cement, Ear, Nose And Throat
ENVOYCEM, MODEL 1640
| Applicant | Envoy Medical Corporation, St. Paul MN, US |
| Decision | Substantially Equivalent, Feb 28, 2008 |
| Received | Jan 7, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080032
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.