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Olympus Winter & Ibe GmbH
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ESG-400 MODEL WB95051N, FOOTSWITCH DOUBLE PEDAL MODEL WB50402W, FOOTSWITCH SINGLE PEDAL MODEL WB50403W, P-CORD MODEL MAJ is an FDA 510(k)-cleared medical device (K103032) manufactured by Olympus Winter & Ibe GmbH. 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 January 13, 2011. Regulation: 8.