FLEXIFLO (R) VERSA-PEG (TM) GASTROSTOMY KIT

FLEXIFLO (R) VERSA-PEG (TM) GASTROSTOMY KIT is an FDA 510(k)-cleared medical device (K903325) manufactured by Abbott Laboratories. 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 November 18, 1990. Regulation: 8.