510(k) K100663

CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321 by Boston Scientific Corporation — Product Code NAJ

K100663 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321". The FDA issued a decision of Substantially Equivalent on April 16, 2010. The device falls under product code NAJ (Agents, Embolic, For Treatment Of Uterine Fibroids), a Class II device regulated under 21 CFR 870.3300. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.