DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM

DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM is an FDA 510(k)-cleared medical device (K072762) manufactured by Depalt, 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 21, 2008. Regulation: 8.