510(k) K051048

SURGISIS STAPLE LINE REINFORCEMENT II by Cook Biotech, Inc. — Product Code FTM

K051048 is an FDA 510(k) premarket notification submitted by Cook Biotech, Inc. for the device "SURGISIS STAPLE LINE REINFORCEMENT II". The FDA issued a decision of Substantially Equivalent on September 23, 2005. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Cook Biotech, Inc. has at least 10 other 510(k) clearances on record.