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Hu-Friedy Mfg. Co., Inc.
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EI DOWNPAK BARRIER SLEEVES is an FDA 510(k)-cleared medical device (K073369) manufactured by Hu-Friedy Mfg. Co., Inc.. This device is classified under the Dental specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 26, 2008. Regulation: 8.