TRUSTEX GRAPE FLAVORED CONDOM IN PURPLE COLOR

TRUSTEX GRAPE FLAVORED CONDOM IN PURPLE COLOR is an FDA 510(k)-cleared medical device (K964591) 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 12, 1997. Regulation: 8.