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Class A Ent.
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DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 610-650, 610-570 is an FDA 510(k)-cleared medical device (K021118) manufactured by Class A Ent.. 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 27, 2002. Regulation: 8.