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Sims Portex, Inc.
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BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT is an FDA 510(k)-cleared medical device (K002506) manufactured by Sims Portex, 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 December 13, 2000. Regulation: 8.