
Hsiner Co., Ltd.
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HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS is an FDA 510(k)-cleared medical device (K082009) 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 August 21, 2008. Regulation: 8.