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Hsiner Co., Ltd.
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CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235 is an FDA 510(k)-cleared medical device (K063268) manufactured by Hsiner Co., Ltd.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 22, 2007. Regulation: 8.