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Smiths Medical International Ltd., Luton
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BABYPAC is an FDA 510(k)-cleared medical device (K043495) manufactured by Smiths Medical International Ltd., Luton. 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 21, 2005. Regulation: 8.