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Pck Electronic Industry & Trade Co., Ltd.
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UROVANTAGE is an FDA 510(k)-cleared medical device (K053279) manufactured by Pck Electronic Industry & Trade Co., Ltd.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 21, 2005. Regulation: 8.