DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE

DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE is an FDA 510(k)-cleared medical device (K950956) 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 June 1, 1995. Regulation: 8.