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Integra Lifesciences Corp.
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DURAGEN XS DURAL REGENERATION MATRIX is an FDA 510(k)-cleared medical device (K072207) 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 August 22, 2007. Regulation: 8.