BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER

BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER is an FDA 510(k)-cleared medical device (K121113) manufactured by Biopsy Sciences, LLC. 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 July 11, 2012. Regulation: 8.