510(k) K050246

SIS DERMAL AUGMENTATION STRAND by Cook Biotech, Inc. — Product Code FTM

K050246 is an FDA 510(k) premarket notification submitted by Cook Biotech, Inc. for the device "SIS DERMAL AUGMENTATION STRAND". The FDA issued a decision of Substantially Equivalent on May 19, 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.