510(k) K112616 ยท ETB Prosthesis, Partial Ossicular Replacement
NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS
| Applicant | Heinz Kurz GmbH Medizintechnik, Amsterdam, NL |
| Decision | Substantially Equivalent, Feb 8, 2013 |
| Received | Sep 8, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112616
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.