510(k) K100360

BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT by Cochlear Americas — Product Code LXB

K100360 is an FDA 510(k) premarket notification submitted by Cochlear Americas for the device "BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT". The FDA issued a decision of Substantially Equivalent on July 13, 2010. The device falls under product code LXB (Hearing Aid, Bone Conduction), a Class II device regulated under 21 CFR 874.3302. Cochlear Americas has at least 10 other 510(k) clearances on record.