510(k) K163212

Parietene DS Composite Mesh by Sofradim Production — Product Code FTL

K163212 is an FDA 510(k) premarket notification submitted by Sofradim Production for the device "Parietene DS Composite Mesh". The FDA issued a decision of Substantially Equivalent on June 29, 2017. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Sofradim Production has at least 10 other 510(k) clearances on record.