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Ascendia Medtech AB
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FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT is an FDA 510(k)-cleared medical device (K050320) manufactured by Ascendia Medtech AB. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 14, 2005. Regulation: 8.