510(k) K896946

COATED NOVAFIL, POLYBUTESTER, MESH by American Cyanamid Co. — Product Code FTM

K896946 is an FDA 510(k) premarket notification submitted by American Cyanamid Co. for the device "COATED NOVAFIL, POLYBUTESTER, MESH". The FDA issued a decision of Substantially Equivalent on May 7, 1990. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. American Cyanamid Co. has at least 6 other 510(k) clearances on record.