PJUR ORIGINAL, PJUR WOMAN, PJUR MAN EXTREME GLIDE

PJUR ORIGINAL, PJUR WOMAN, PJUR MAN EXTREME GLIDE is an FDA 510(k)-cleared medical device (K133233) manufactured by Pjur Group Luxembourg S.A.. 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 July 17, 2014. Regulation: 8.