510(k) K932115

ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMI by Blairden Precision Instruments, Inc. — Product Code LKF

K932115 is an FDA 510(k) premarket notification submitted by Blairden Precision Instruments, Inc. for the device "ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMI". The FDA issued a decision of Substantially Equivalent on June 24, 1994. The device falls under product code LKF (Cannula, Manipulator/Injector, Uterine), a Class II device regulated under 21 CFR 884.4530. Blairden Precision Instruments, Inc. has at least 1 other 510(k) clearance on record.