TROJAN PASSION BERRY GEL

TROJAN PASSION BERRY GEL is an FDA 510(k)-cleared medical device (K013433) manufactured by Armkel, 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 March 4, 2002. Regulation: 8.