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Smith & Nephew Inc., Endoscopy Division
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ENDOBUTTON CONTINUOUS LOOP (CL) is an FDA 510(k)-cleared medical device (K081098) manufactured by Smith & Nephew Inc., Endoscopy Division. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 15, 2008. Regulation: 8.