TRUSTEX COLA FLAVORD CONDOM

TRUSTEX COLA FLAVORD CONDOM is an FDA 510(k)-cleared medical device (K964598) manufactured by Line One Laboratories. 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 February 13, 1997. Regulation: 8.