IYUNNI 3ID TRI-FUNNEL GASTROSTOMY TUBE KIT

IYUNNI 3ID TRI-FUNNEL GASTROSTOMY TUBE KIT is an FDA 510(k)-cleared medical device (K092049) manufactured by Sainath Intellectual Properties, LLC. 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 October 8, 2009. Regulation: 8.