PH BUFFERING PLASTIC APPLICATOR TAMPON

PH BUFFERING PLASTIC APPLICATOR TAMPON is an FDA 510(k)-cleared medical device (K030474) manufactured by Rostam , Ltd.. 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 May 27, 2004. Regulation: 8.