GORE-TEX(R) CURVED SURGICALMEMBRANE

GORE-TEX(R) CURVED SURGICALMEMBRANE is an FDA 510(k)-cleared medical device (K945899) 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 February 12, 1995. Regulation: 8.