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Hemedex Incorporated
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HEMEDEX CRANIAL BOLT MODELS, 3601, 3602 is an FDA 510(k)-cleared medical device (K032337) manufactured by Hemedex Incorporated. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 20, 2003. Regulation: 8.