510(k) K051914

GENEROS 80, GENEROS 60 by Berkeley Advanced Biomaterials, Inc. — Product Code MQV

K051914 is an FDA 510(k) premarket notification submitted by Berkeley Advanced Biomaterials, Inc. for the device "GENEROS 80, GENEROS 60". The FDA issued a decision of Substantially Equivalent on November 3, 2005. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Berkeley Advanced Biomaterials, Inc. has at least 10 other 510(k) clearances on record.