510(k) K913285 ยท ETB Prosthesis, Partial Ossicular Replacement
PTFE PISTON
| Applicant | River Medical, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Dec 18, 1991 |
| Received | Jul 24, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913285
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.