MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE

MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE is an FDA 510(k)-cleared medical device (K001616) manufactured by Abbott Laboratories. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 26, 2000. Regulation: 8.