COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX

COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX is an FDA 510(k)-cleared medical device (K001916) manufactured by Novartis Nutrition Corp.. 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 15, 2001. Regulation: 8.