CORE-RESISTANT HUBER INFUSION SET WITH Y-SITE

CORE-RESISTANT HUBER INFUSION SET WITH Y-SITE is an FDA 510(k)-cleared medical device (K950597) manufactured by Distronic Sterile Products, 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 July 25, 1995. Regulation: 8.