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Sofradim Production
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PROGRIP LAPARSCOPIC SELF-FIXATING MESH is an FDA 510(k)-cleared medical device (K120897) 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 June 28, 2012. Regulation: 8.