510(k) K823912 ยท ETA Replacement, Ossicular Prosthesis, Total
AUSTIN MODIFIED TOTAL OSSICULAR REPLACE
| Applicant | Treace Medical, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 24, 1983 |
| Received | Dec 28, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K823912
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.