UNIDUS MALE LATEX CONDOM (WITH COLOR AND FLAVORING)

UNIDUS MALE LATEX CONDOM (WITH COLOR AND FLAVORING) is an FDA 510(k)-cleared medical device (K023175) manufactured by Unidus Corp.. 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 December 12, 2002. Regulation: 8.