510(k) K130512 ยท ETB Prosthesis, Partial Ossicular Replacement
NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS
| Applicant | Heinz Kurz GmbH Medizintechnik, Dusslingen, DE |
| Decision | Substantially Equivalent, Dec 2, 2013 |
| Received | Feb 27, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130512
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.