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Shinchang Medical Co., Ltd.
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SC PROFI FINE PEN NEEDLE, MODELS; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G) is an FDA 510(k)-cleared medical device (K070988) manufactured by Shinchang Medical Co., Ltd.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 22, 2007. Regulation: 8.

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