ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMI

ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMI is an FDA 510(k)-cleared medical device (K932115) manufactured by Blairden Precision Instruments, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 23, 1994. Regulation: 8.