510(k) K033554 ยท ETB Prosthesis, Partial Ossicular Replacement
SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS
| Applicant | Gyrus Ent LLC, Bartlett TN, US |
| Decision | Substantially Equivalent, Nov 24, 2003 |
| Received | Nov 12, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033554
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.