510(k) K942583

PERI-STRIPS PLANAR CONFIGURATION STAPLE LINE REINFORCEMENT by Bio-Vascular, Inc. — Product Code FTL

K942583 is an FDA 510(k) premarket notification submitted by Bio-Vascular, Inc. for the device "PERI-STRIPS PLANAR CONFIGURATION STAPLE LINE REINFORCEMENT". The FDA issued a decision of Substantially Equivalent on July 8, 1994. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Bio-Vascular, Inc. has at least 10 other 510(k) clearances on record.