SIMPLICITY SILVER SET SOFT INFUSION

SIMPLICITY SILVER SET SOFT INFUSION is an FDA 510(k)-cleared medical device (K010846) 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 April 11, 2001. Regulation: 8.