510(k) K950984 ยท ETB Prosthesis, Partial Ossicular Replacement
HAPES MALLEABLE INCUS STAPES
| Applicant | Smith & Nephew Richards, Inc., Bartlett TN, US |
| Decision | Substantially Equivalent, Mar 15, 1995 |
| Received | Mar 3, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950984
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.