FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS

FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS is an FDA 510(k)-cleared medical device (K032173) manufactured by First Quality Hygienic, 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 2, 2003. Regulation: 8.