510(k) K130307

ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHERE by Celonova Biosciences, Inc. — Product Code KRD

K130307 is an FDA 510(k) premarket notification submitted by Celonova Biosciences, Inc. for the device "ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHERE". The FDA issued a decision of Substantially Equivalent on March 4, 2013. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300. Celonova Biosciences, Inc. has at least 4 other 510(k) clearances on record.