PRECLUDE ACUSEAL DURA SUBSTITUTE

PRECLUDE ACUSEAL DURA SUBSTITUTE is an FDA 510(k)-cleared medical device (K984534) manufactured by W. L. Gore & Associates, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 14, 1999. Regulation: 8.