ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON

ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON is an FDA 510(k)-cleared medical device (K983478) manufactured by Organic Essentials. 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 November 8, 1998. Regulation: 8.