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Togo Medikit Co., Ltd.
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SUPER SHEATH XL INTRODUCER SHEATH is an FDA 510(k)-cleared medical device (K060190) manufactured by Togo Medikit Co., Ltd.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 3, 2006. Regulation: 8.