
Vygon SA
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BOUSSIGNAC/VYGON ENDOTRACHEAL TUBE, MODEL 6501.25/30/35 AND 6502.70/75/80 is an FDA 510(k)-cleared medical device (K040657) manufactured by Vygon SA. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 9, 2004. Regulation: 8.