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Somatex Medical Technologies GmbH
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TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560 is an FDA 510(k)-cleared medical device (K093064) manufactured by Somatex Medical Technologies GmbH. 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 16, 2010. Regulation: 8.