MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE

MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE is an FDA 510(k)-cleared medical device (K063613) manufactured by Terumo Medical 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 December 25, 2006. Regulation: 8.