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Sturdy Industrial Co., Ltd.
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STURDY MANUAL RESUSCITATOR is an FDA 510(k)-cleared medical device (K032596) manufactured by Sturdy Industrial 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 4, 2004. Regulation: 8.