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Medipack Medical Packaging Mfg. Co.
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EARLOOP PROCEDURE MASK is an FDA 510(k)-cleared medical device (K034015) manufactured by Medipack Medical Packaging Mfg. Co.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 19, 2004. Regulation: 8.