510(k) K082245

AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV by Ceremed , Inc. — Product Code KHJ

K082245 is an FDA 510(k) premarket notification submitted by Ceremed , Inc. for the device "AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV". The FDA issued a decision of Substantially Equivalent on September 18, 2008. The device falls under product code KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)), a Class II device regulated under 21 CFR 874.3620. Ceremed , Inc. has at least 10 other 510(k) clearances on record.