PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS

PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS is an FDA 510(k)-cleared medical device (K132819) manufactured by Playtex Manufacturing, 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 October 8, 2013. Regulation: 8.