HydroMARK Breast Biopsy Site Marker — Devicor Medical Products, Inc. (510(k) K161021)
HydroMARK Breast Biopsy Site Marker — Devicor Medical Products, Inc. (510(k) K161021) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: HydroMARK Breast Biopsy Site Marker; Applicant: Devicor Medical Products, Inc.; Clearance track: 510(k).
| Device name | HydroMARK Breast Biopsy Site Marker |
|---|---|
| Applicant | Devicor Medical Products, Inc. |
| Clearance track | 510(k) |
| Submission number | K161021 |
| Decision | Substantially Equivalent |
| Decision date | 2016-05-05 |
| Date received | 2016-04-12 |
| Product code | NEU |
| Device class | 2 |
| Medical specialty | General, Plastic Surgery |
| Applicant location | OH, US |
| Source | openFDA device |
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