CONDOMS (RAMSES EXTRA, SHEIK ELITE AND KOROMEX)

CONDOMS (RAMSES EXTRA, SHEIK ELITE AND KOROMEX) is an FDA 510(k)-cleared medical device (K874791) manufactured by Schmid Laboratories, 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 April 11, 1988. Regulation: 8.