ONTEX TAMPON (UNSCENTED)

ONTEX TAMPON (UNSCENTED) is an FDA 510(k)-cleared medical device (K090819) manufactured by Ontex International NV. 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 December 22, 2009. Regulation: 8.