SIMPLICITY QD SOFT INFUSION SET FOR USE BY PEOPLE WITH DIABETES IN INFUSE INSULIN SUBCUTANEOUSLY FROM A PUMP OR SYRINGE

SIMPLICITY QD SOFT INFUSION SET FOR USE BY PEOPLE WITH DIABETES IN INFUSE INSULIN SUBCUTANEOUSLY FROM A PUMP OR SYRINGE is an FDA 510(k)-cleared medical device (K013104) 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 October 1, 2001. Regulation: 8.