SURGI-WRAP MAST TENDON SHEET

SURGI-WRAP MAST TENDON SHEET is an FDA 510(k)-cleared medical device (K063648) manufactured by Mast Biosurgery USA, 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 March 6, 2007. Regulation: 8.