510(k) K963076

LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY by Louisville Laboratories, Inc. — Product Code HET

K963076 is an FDA 510(k) premarket notification submitted by Louisville Laboratories, Inc. for the device "LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY". The FDA issued a decision of Substantially Equivalent on April 4, 1997. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. Louisville Laboratories, Inc. has at least 10 other 510(k) clearances on record.