ELUTIA COATED CLOSED SURGICAL WOUND DRAIN

ELUTIA COATED CLOSED SURGICAL WOUND DRAIN is an FDA 510(k)-cleared medical device (K063245) manufactured by Bacterin International, 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 November 27, 2007. Regulation: 8.