UROVISION JANUS

UROVISION JANUS is an FDA 510(k)-cleared medical device (K953353) manufactured by Life-Tech Intl., Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 7, 1995. Regulation: 8.