510(k) K915121 ยท ETB Prosthesis, Partial Ossicular Replacement
TEF/WIRE PISTON
| Applicant | River Medical, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Dec 23, 1991 |
| Received | Nov 13, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915121
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.