510(k) K111692 ยท NEU Marker, Radiographic, Implantable
TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC
| Applicant | Somatex Medical Technologies GmbH, Wurmlingen, DE |
| Decision | Substantially Equivalent, Nov 8, 2011 |
| Received | Jun 16, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111692
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.