DURA-GUARD-DURAL REPAIR PATCH

DURA-GUARD-DURAL REPAIR PATCH is an FDA 510(k)-cleared medical device (K973706) manufactured by Bio-Vascular, 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 December 23, 1997. Regulation: 8.