510(k) K203097 ยท NEU Marker, Radiographic, Implantable
HydroMARK Breast Biopsy Site Markers
| Applicant | Devicor Medical Products, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Dec 16, 2020 |
| Received | Oct 14, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203097
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.