510(k) K161021 ยท NEU Marker, Radiographic, Implantable
HydroMARK Breast Biopsy Site Marker
| Applicant | Devicor Medical Products, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, May 5, 2016 |
| Received | Apr 12, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161021
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.