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Sofradim Production
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PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES is an FDA 510(k)-cleared medical device (K050187) manufactured by Sofradim Production. 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 February 17, 2005. Regulation: 8.