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Class A Enterprises, Inc.
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LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812 is an FDA 510(k)-cleared medical device (K023472) manufactured by Class A Enterprises, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 17, 2003. Regulation: 8.