DURA-GUARD - DURAL REPAIR PATCH

DURA-GUARD - DURAL REPAIR PATCH is an FDA 510(k)-cleared medical device (K982282) 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 July 29, 1998. Regulation: 8.