1351 UROFLOW AUTO START

1351 UROFLOW AUTO START is an FDA 510(k)-cleared medical device (K853936) 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 December 1, 1985. Regulation: 8.