MODIFICATION TO EZ HUBER SAFETY INFUSION SET

MODIFICATION TO EZ HUBER SAFETY INFUSION SET is an FDA 510(k)-cleared medical device (K071846) manufactured by Pfm Medical, 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 August 29, 2007. Regulation: 8.