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Cook Urological, Inc.
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COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W is an FDA 510(k)-cleared medical device (K080525) manufactured by Cook Urological, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 16, 2008. Regulation: 8.