510(k) K083780 ยท ETA Replacement, Ossicular Prosthesis, Total
SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2
| Applicant | Audio Technologies S.R.L., Piacenza, IT |
| Decision | Substantially Equivalent, Mar 23, 2009 |
| Received | Dec 19, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083780
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.