DUREX PLAY LUBRICANT

DUREX PLAY LUBRICANT is an FDA 510(k)-cleared medical device (K032124) manufactured by Ssl Americas, 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 January 15, 2004. Regulation: 8.