
Devicor Medical Products, Inc.
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HydroMARK Breast Biopsy Site Marker is an FDA 510(k)-cleared medical device (K212158) manufactured by Devicor Medical Products, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 20, 2022. Regulation: 8.