510(k) K070738

SIS FACIAL CYLINDER, SIS FACIAL IMPLANT by Cook Biotech, Inc. — Product Code FTM

K070738 is an FDA 510(k) premarket notification submitted by Cook Biotech, Inc. for the device "SIS FACIAL CYLINDER, SIS FACIAL IMPLANT". The FDA issued a decision of Substantially Equivalent on April 5, 2007. 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.