
Biopsy Sciences, LLC
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BIOPSY SCIENCES, INC., HYDROMARK BREAST BIOPSY SITE MARKER is an FDA 510(k)-cleared medical device (K083006) 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 February 8, 2009. Regulation: 8.