510(k) K911583 ยท ETA Replacement, Ossicular Prosthesis, Total
IONOS(R) OSSICLE 5MM & 7MM
| Applicant | Ionos GmbH & Co. KG, Germany, DE |
| Decision | Substantially Equivalent, Sep 9, 1991 |
| Received | Apr 8, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911583
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.