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Lake Region Mfg., Inc.
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MODIFIED HYDROPHILIC COATED GUIDEWIRE is an FDA 510(k)-cleared medical device (K000011) manufactured by Lake Region Mfg., Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 29, 2000. Regulation: 8.