510(k) K962564 ยท ETB Prosthesis, Partial Ossicular Replacement
RICHARDS TOTAL/PARTIAL PROSTHESIS
| Applicant | Gyrus Ent LLC, Bartlett TN, US |
| Decision | Substantially Equivalent, Jan 22, 1997 |
| Received | Jul 1, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962564
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.