PJUR(R) SILICONEGEL, PJUR(R) BASIC PERSONAL GLIDE, PJUR(R) LIGHT, PJUR(R) MED PREMIUM GLIDE

PJUR(R) SILICONEGEL, PJUR(R) BASIC PERSONAL GLIDE, PJUR(R) LIGHT, PJUR(R) MED PREMIUM GLIDE is an FDA 510(k)-cleared medical device (K133336) 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 23, 2014. Regulation: 8.