DURAGEN DURAL GRAFT MATRIX

DURAGEN DURAL GRAFT MATRIX is an FDA 510(k)-cleared medical device (K982180) manufactured by Integra Lifesciences Corp.. 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 5, 1999. Regulation: 8.