EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9

EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9 is an FDA 510(k)-cleared medical device (K972430) 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 September 9, 1997. Regulation: 8.