DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML

DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML is an FDA 510(k)-cleared medical device (K020666) manufactured by Baxter Healthcare Corp. 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 June 23, 2002. Regulation: 8.