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Medstone Intl., Inc.
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MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION is an FDA 510(k)-cleared medical device (K013620) manufactured by Medstone Intl., Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 21, 2002. Regulation: 8.