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Depuy Mitek, A Johnson & Johnson Company
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3.5 MM SIDE EFFECT ELECTRODE WITH INTEGRATED HANDPIECE, MODEL 227301, 3.5 MM ANGLED SIDE EFFECT ELECTRODE WITH INTEGRATE is an FDA 510(k)-cleared medical device (K082643) manufactured by Depuy Mitek, A Johnson & Johnson Company. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 18, 2008. Regulation: 8.