About This 510(k) Submission
K142908 is an FDA 510(k) clearance for the Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh, a Mesh, Surgical, Polymeric (Class II — Special Controls, product code FTL), submitted by Sofradim Production (Tr?voux, FR). The FDA issued a Cleared decision on November 14, 2014, 39 days after receiving the submission on October 6, 2014. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.