CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTH

CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTH is an FDA 510(k)-cleared medical device (K970767) manufactured by Custom Services Intl., Inc.. 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 June 1, 1997. Regulation: 8.