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Lake Region Medical
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MANDREL GUIDEWIRES OR M-WIRE is an FDA 510(k)-cleared medical device (K080508) manufactured by Lake Region Medical. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 20, 2008. Regulation: 8.

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