BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE

BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE is an FDA 510(k)-cleared medical device (K063118) manufactured by C.R. Bard, 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 12, 2007. Regulation: 8.