510(k) K133447

EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES by Celonova Biosciences, Inc. — Product Code NAJ

K133447 is an FDA 510(k) premarket notification submitted by Celonova Biosciences, Inc. for the device "EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES". The FDA issued a decision of Substantially Equivalent on February 24, 2014. The device falls under product code NAJ (Agents, Embolic, For Treatment Of Uterine Fibroids), a Class II device regulated under 21 CFR 870.3300. Celonova Biosciences, Inc. has at least 4 other 510(k) clearances on record.