510(k) K092046

BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY by Berkeley Advanced Biomaterials, Inc. — Product Code MQV

K092046 is an FDA 510(k) premarket notification submitted by Berkeley Advanced Biomaterials, Inc. for the device "BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY". The FDA issued a decision of Substantially Equivalent on March 24, 2010. 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.