CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACORE

CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACORE is an FDA 510(k)-cleared medical device (K935512) manufactured by Corpak Co.. 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 August 28, 1996. Regulation: 8.