510(k) K002464 ยท ETB Prosthesis, Partial Ossicular Replacement
SMITH & NEPHEW OFF-CENTERED PORP
| Applicant | Gyrus Ent LLC, Bartlett TN, US |
| Decision | Substantially Equivalent, Aug 29, 2000 |
| Received | Aug 10, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002464
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.