510(k) K893134 ยท ETB Prosthesis, Partial Ossicular Replacement
APACERAM OSSICULAR PROSTHESIS
| Applicant | Asahi Optical Co. C/O Rosati Associates, P.C., Birmingham MI, US |
| Decision | Substantially Equivalent, Aug 3, 1989 |
| Received | Apr 25, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K893134
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.