
Cardinal Health 207, Inc.
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THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK is an FDA 510(k)-cleared medical device (K081670) manufactured by Cardinal Health 207, 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 October 8, 2008. Regulation: 8.