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Taewoong Medical Co., Ltd.
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NITI-S STENT & INTRODUCER, MODEL EOXXXX is an FDA 510(k)-cleared medical device (K041648) manufactured by Taewoong Medical Co., 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 April 27, 2005. Regulation: 8.