GORE SEAMGUARD REINFORCEMENT

GORE SEAMGUARD REINFORCEMENT is an FDA 510(k)-cleared medical device (K131658) manufactured by W. L. Gore & Associates, 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 5, 2013. Regulation: 8.