GORE POLYPROPYLENE HERNIA MESH

GORE POLYPROPYLENE HERNIA MESH is an FDA 510(k)-cleared medical device (K043081) 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 December 21, 2004. Regulation: 8.