510(k) K001902 ยท ETA Replacement, Ossicular Prosthesis, Total
BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD
| Applicant | Gyrus Ent LLC, Bartlett TN, US |
| Decision | Substantially Equivalent, Jul 10, 2000 |
| Received | Jun 22, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001902
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.