MRI'S ALL SILICONE GASTROSTOMY TUBE

MRI'S ALL SILICONE GASTROSTOMY TUBE is an FDA 510(k)-cleared medical device (K951489) manufactured by Manufacturing & Research, 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 June 6, 1995. Regulation: 8.