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Olympus Medical Systems Corporation
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HIGH FLOW INSUFFLANTION UNIT is an FDA 510(k)-cleared medical device (K122180) manufactured by Olympus Medical Systems Corporation. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 12, 2012. Regulation: 8.

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