510(k) K042811

VIVOSORB SHEET, MODEL FS01 by Polyganics B.V., — Product Code FTL

K042811 is an FDA 510(k) premarket notification submitted by Polyganics B.V., for the device "VIVOSORB SHEET, MODEL FS01". The FDA issued a decision of Substantially Equivalent on November 8, 2004. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Polyganics B.V., has at least 8 other 510(k) clearances on record.