510(k) K932394

BERNSTEIN(TM) UTERINE MANIPULATOR by Gm Engineering, Inc. — Product Code LKF

K932394 is an FDA 510(k) premarket notification submitted by Gm Engineering, Inc. for the device "BERNSTEIN(TM) UTERINE MANIPULATOR". The FDA issued a decision of Substantially Equivalent on January 26, 1995. The device falls under product code LKF (Cannula, Manipulator/Injector, Uterine), a Class II device regulated under 21 CFR 884.4530. Gm Engineering, Inc. has at least 10 other 510(k) clearances on record.