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Semperit Technische Produkte Gesellshaft
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SEMPERMED SUPREME, SIZES 5.5, 6, 6.5, 7, 7.5, 8, 8.5, AND 9 is an FDA 510(k)-cleared medical device (K013560) manufactured by Semperit Technische Produkte Gesellshaft. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 15, 2002. Regulation: 8.