INNERWEAR, JIMMY-O RAINCOAT, RAINCOAT, JASMINE, DRINK

INNERWEAR, JIMMY-O RAINCOAT, RAINCOAT, JASMINE, DRINK is an FDA 510(k)-cleared medical device (K972427) 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 August 19, 1997. Regulation: 8.