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Medicatech USA
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MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA is an FDA 510(k)-cleared medical device (K080582) manufactured by Medicatech USA. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 14, 2008. Regulation: 8.