510(k) K954518 ยท ETA Replacement, Ossicular Prosthesis, Total
TREBAY TOTAL RECTANGULAR HEAD
| Applicant | Trebay Medical Corp., Clearwater FL, US |
| Decision | Substantially Equivalent, Oct 27, 1995 |
| Received | Sep 28, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954518
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.