PARIETEX MONOFILAMENT POLYESTER MESH

PARIETEX MONOFILAMENT POLYESTER MESH is an FDA 510(k)-cleared medical device (K090858) 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 May 5, 2009. Regulation: 8.