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Promedical Products Co., Ltd.
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PROMEDICAL SURGICAL DRAPES is an FDA 510(k)-cleared medical device (K042131) manufactured by Promedical Products 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 December 9, 2004. Regulation: 8.