MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE

MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE is an FDA 510(k)-cleared medical device (K091583) manufactured by Medefil, Inc.. 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 January 27, 2010. Regulation: 8.