MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET

MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET is an FDA 510(k)-cleared medical device (K031955) manufactured by Macropore Biosurgery, 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 September 21, 2003. Regulation: 8.