PRE' VAGINAL LUBRICANT

PRE' VAGINAL LUBRICANT is an FDA 510(k)-cleared medical device (K051436) manufactured by Ingfertlity, LLC. 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 October 12, 2006. Regulation: 8.