510(k) K070093

OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE by Ceremed , Inc. — Product Code KHJ

K070093 is an FDA 510(k) premarket notification submitted by Ceremed , Inc. for the device "OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE". The FDA issued a decision of Substantially Equivalent on January 24, 2007. 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.