510(k) K071776

ANEUROPLASTIC, MODEL 43-1290 by Codman & Shurtleff, Inc. — Product Code JXH

K071776 is an FDA 510(k) premarket notification submitted by Codman & Shurtleff, Inc. for the device "ANEUROPLASTIC, MODEL 43-1290". The FDA issued a decision of Substantially Equivalent on July 26, 2007. The device falls under product code JXH (Methyl Methacrylate For Aneurysmorrhaphy), a Class II device regulated under 21 CFR 882.5030. Codman & Shurtleff, Inc. has at least 10 other 510(k) clearances on record.