510(k) K925443 ยท ETB Prosthesis, Partial Ossicular Replacement
INCUDOSTAPEDIAL JOINT
| Applicant | Smith & Nephew Richards, Inc., Bartlett TN, US |
| Decision | Substantially Equivalent, Mar 8, 1993 |
| Received | Oct 28, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K925443
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.