RUSCH BLAKEMORE 3 LUMEN, STERILE

RUSCH BLAKEMORE 3 LUMEN, STERILE is an FDA 510(k)-cleared medical device (K981203) 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 4, 1998. Regulation: 8.