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Covidien UK Manufacturing, Ltd.
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IVS TUNNELLER DEVICES is an FDA 510(k)-cleared medical device (K073164) manufactured by Covidien UK Manufacturing, Ltd.. 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 March 4, 2008. Regulation: 8.