510(k) K000858 ยท ETB Prosthesis, Partial Ossicular Replacement
WEHRS INCUS-STAPES
| Applicant | Gyrus Ent LLC, Bartlett TN, US |
| Decision | Substantially Equivalent, Apr 3, 2000 |
| Received | Mar 16, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000858
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.