CATHEJELL S STERILE LUBRICATING JELLY

CATHEJELL S STERILE LUBRICATING JELLY is an FDA 510(k)-cleared medical device (K935548) manufactured by Pharmazeutische Fabrik Montavit GmbH. 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 March 29, 1994. Regulation: 8.