
Smiths Medical Asd, Inc.
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BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES is an FDA 510(k)-cleared medical device (K081440) manufactured by Smiths Medical Asd, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 11, 2008. Regulation: 8.