SAFECON CONDOMS W/SPERMICIDAL LUBRICANT

SAFECON CONDOMS W/SPERMICIDAL LUBRICANT is an FDA 510(k)-cleared medical device (K883524) manufactured by Quality Synthetics 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 March 28, 1989. Regulation: 8.