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Wellmien (Suzhou) Import & Export Trading Co., Ltd.
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WELLMIEN SURGICAL MASK is an FDA 510(k)-cleared medical device (K101000) manufactured by Wellmien (Suzhou) Import & Export Trading 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 August 8, 2010. Regulation: 8.