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Tracoe Medical GmbH
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TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO is an FDA 510(k)-cleared medical device (K043160) 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 February 17, 2005. Regulation: 8.