DISPO-URETTE

DISPO-URETTE is an FDA 510(k)-cleared medical device (K860796) manufactured by Roland J. Zwick, 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 April 7, 1986. Regulation: 8.