COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI)

COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI) is an FDA 510(k)-cleared medical device (K932983) manufactured by Sime Health, Ltd.. 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 July 6, 1994. Regulation: 8.