510(k) K082491

OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, AOC, OSTENE, OSTEOTENE & CERETENE by Ceremed , Inc. — Product Code MTJ

K082491 is an FDA 510(k) premarket notification submitted by Ceremed , Inc. for the device "OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, AOC, OSTENE, OSTEOTENE & CERETENE". The FDA issued a decision of Substantially Equivalent on September 24, 2008. The device falls under product code MTJ (Wax, Bone), a Class U device. Ceremed , Inc. has at least 10 other 510(k) clearances on record.