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Munktell Filter AB
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GARD FILTER, COMBIGARD FILTE / HME is an FDA 510(k)-cleared medical device (K014281) manufactured by Munktell Filter AB. 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 25, 2002. Regulation: 8.