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Plastiflex Group NV
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HYBERNITE RAINOUT CONTROL SYSTEM is an FDA 510(k)-cleared medical device (K100104) manufactured by Plastiflex Group NV. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 13, 2010. Regulation: 8.