ORION LIFE SYSTEMS REPLACEMENT GASTROSTOMY TUBE

ORION LIFE SYSTEMS REPLACEMENT GASTROSTOMY TUBE is an FDA 510(k)-cleared medical device (K904801) manufactured by Orion Life Systems, 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 January 15, 1991. Regulation: 8.