STERILIZATION OF GORE-TEX SOFT TISSU

STERILIZATION OF GORE-TEX SOFT TISSU is an FDA 510(k)-cleared medical device (K833764) 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 January 9, 1984. Regulation: 8.