510(k) K092980

PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5 by Panpac Medical Corporation — Product Code LKF

K092980 is an FDA 510(k) premarket notification submitted by Panpac Medical Corporation for the device "PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5". The FDA issued a decision of Substantially Equivalent on March 11, 2010. The device falls under product code LKF (Cannula, Manipulator/Injector, Uterine), a Class II device regulated under 21 CFR 884.4530. Panpac Medical Corporation has at least 10 other 510(k) clearances on record.