SIMPLICITY SOFT QD SILVER INFUSION SET

SIMPLICITY SOFT QD SILVER INFUSION SET is an FDA 510(k)-cleared medical device (K011580) manufactured by Sterling Medivations, 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 June 4, 2001. Regulation: 8.