LAPAROSCOPIC GASTROSTOMY KIT

LAPAROSCOPIC GASTROSTOMY KIT is an FDA 510(k)-cleared medical device (K973891) manufactured by Applied Medical Resources. 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 11, 1998. Regulation: 8.