RUSCH FLONEIL; FLOCATH INTROGEL

RUSCH FLONEIL; FLOCATH INTROGEL is an FDA 510(k)-cleared medical device (K020714) manufactured by Rusch Intl.. 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 June 30, 2002. Regulation: 8.