510(k) K843461 ยท ETA Replacement, Ossicular Prosthesis, Total
BIOGLASS OSSICULAR RECONSTRUCTION PROSTH
| Applicant | American Biomaterials Corp., Princeton NJ, US |
| Decision | Substantially Equivalent, Jan 9, 1985 |
| Received | Sep 5, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K843461
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.