510(k) K964909 ยท ETB Prosthesis, Partial Ossicular Replacement
ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS
| Applicant | Xomed, Inc., Jacksonville FL, US |
| Decision | Substantially Equivalent, Mar 10, 1997 |
| Received | Dec 9, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964909
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.