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Vanduzen Dba Medcad
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MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT is an FDA 510(k)-cleared medical device (K110684) manufactured by Vanduzen Dba Medcad. 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 23, 2011. Regulation: 8.