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Collagen Matrix, Inc.
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DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE is an FDA 510(k)-cleared medical device (K061487) manufactured by Collagen Matrix, 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 25, 2006. Regulation: 8.