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Mri Devices Corporation
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HRW-63-8 WRIST ARRAY COIL; HRW-127-8 WRIST ARRAY COIL is an FDA 510(k)-cleared medical device (K050622) manufactured by Mri Devices Corporation. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 7, 2005. Regulation: 8.