VACURECT VACUUM CONSTRICTION DEVICE

VACURECT VACUUM CONSTRICTION DEVICE is an FDA 510(k)-cleared medical device (K032776) manufactured by Vacurect Manufacturing (Pty) , Ltd.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 2, 2003. Regulation: 8.