SOFRADIM PARIETEX SURGICAL MESHES

SOFRADIM PARIETEX SURGICAL MESHES is an FDA 510(k)-cleared medical device (K003990) 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 January 23, 2001. Regulation: 8.