510(k) K034039

SIS PLASTIC SURGERY MATRIX by Cook Biotech, Inc. — Product Code FTM

K034039 is an FDA 510(k) premarket notification submitted by Cook Biotech, Inc. for the device "SIS PLASTIC SURGERY MATRIX". The FDA issued a decision of Substantially Equivalent on February 18, 2004. 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.