DISPOSABLE URODYNAMIC CATHETER SET

DISPOSABLE URODYNAMIC CATHETER SET is an FDA 510(k)-cleared medical device (K896784) 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 February 15, 1990. Regulation: 8.