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Tracoe Medical GmbH
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TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470 is an FDA 510(k)-cleared medical device (K051587) manufactured by Tracoe Medical GmbH. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 24, 2005. Regulation: 8.