MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS

MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS is an FDA 510(k)-cleared medical device (K082278) manufactured by Ethicon Endo-Sugery, 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 December 15, 2008. Regulation: 8.