ROMBEAU GASTROSTOMY-JEJUNAL TUBE

ROMBEAU GASTROSTOMY-JEJUNAL TUBE is an FDA 510(k)-cleared medical device (K822380) manufactured by Hedeco. 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 September 16, 1982. Regulation: 8.