510(k) K081768

COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES by Cook Incorporated — Product Code NAJ

K081768 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES". The FDA issued a decision of Substantially Equivalent on December 23, 2008. The device falls under product code NAJ (Agents, Embolic, For Treatment Of Uterine Fibroids), a Class II device regulated under 21 CFR 870.3300. Cook Incorporated has at least 10 other 510(k) clearances on record.