
Shanghai Pudong Jinhuan Medical Products Co., Ltd.
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ABSORBABLE SYNTHETIC SUTURE WITH NEEDLE ATTACHMENT (PGA BRAIDED) is an FDA 510(k)-cleared medical device (K080412) manufactured by Shanghai Pudong Jinhuan Medical 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 September 3, 2008. Regulation: 8.