TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001

TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001 is an FDA 510(k)-cleared medical device (K000416) manufactured by Retinalabs.Com. 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 May 7, 2000. Regulation: 8.