GORE-TEX TISSUE REINFORCEMENT PATCH

GORE-TEX TISSUE REINFORCEMENT PATCH is an FDA 510(k)-cleared medical device (K820193) 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 March 25, 1982. Regulation: 8.