GORE-TEX(R) EXPANDED PTFE SURGICAL MEMBRANE

GORE-TEX(R) EXPANDED PTFE SURGICAL MEMBRANE is an FDA 510(k)-cleared medical device (K910464) manufactured by W. L. Gore & Associates, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 25, 1991. Regulation: 8.