510(k) K013104

SIMPLICITY QD SOFT INFUSION SET FOR USE BY PEOPLE WITH DIABETES IN INFUSE INSULIN SUBCUTANEOUSLY FROM A PUMP OR SYRINGE by Sterling Medivations, Inc. — Product Code FPA

K013104 is an FDA 510(k) premarket notification submitted by Sterling Medivations, Inc. for the device "SIMPLICITY QD SOFT INFUSION SET FOR USE BY PEOPLE WITH DIABETES IN INFUSE INSULIN SUBCUTANEOUSLY FROM A PUMP OR SYRINGE". The FDA issued a decision of Substantially Equivalent on Oct 2, 2001. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Sterling Medivations, Inc. has 26 other 510(k) clearances on record.