510(k) K121964 ยท NEU Marker, Radiographic, Implantable
MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML
| Applicant | Augmenix, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Jan 23, 2013 |
| Received | Jul 5, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121964
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.