510(k) K953034

H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) by Ackrad Laboratories — Product Code LKF

K953034 is an FDA 510(k) premarket notification submitted by Ackrad Laboratories for the device "H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)". The FDA issued a decision of Substantially Equivalent on August 29, 1995. The device falls under product code LKF (Cannula, Manipulator/Injector, Uterine), a Class II device regulated under 21 CFR 884.4530. Ackrad Laboratories has at least 10 other 510(k) clearances on record.