510(k) K971048

PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT by Bio-Vascular, Inc. — Product Code FTM

K971048 is an FDA 510(k) premarket notification submitted by Bio-Vascular, Inc. for the device "PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT". The FDA issued a decision of Substantially Equivalent on May 9, 1997. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Bio-Vascular, Inc. has at least 10 other 510(k) clearances on record.