510(k) K032388

BONE CEMENT RADIO-OPACIFIER by Cardinalhealth — Product Code MYU

K032388 is an FDA 510(k) premarket notification submitted by Cardinalhealth for the device "BONE CEMENT RADIO-OPACIFIER". The FDA issued a decision of Substantially Equivalent on October 31, 2003. The device falls under product code MYU (Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty), a Class II device regulated under 21 CFR 882.5300. Cardinalhealth has at least 10 other 510(k) clearances on record.