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Hand Biomechanics Lab, Inc.
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WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS is an FDA 510(k)-cleared medical device (K030519) manufactured by Hand Biomechanics Lab, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 9, 2003. Regulation: 8.