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Macropore Biosurgery, Inc.
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MACROPORENS CRANILOC is an FDA 510(k)-cleared medical device (K002334) manufactured by Macropore Biosurgery, 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 May 1, 2001. Regulation: 8.