510(k) K013767

SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUDING INSULIN, FROM AN EXTERNAL INFUSION PUMP by Sterling Medivations, Inc. — Product Code FRN

K013767 is an FDA 510(k) premarket notification submitted by Sterling Medivations, Inc. for the device "SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUDING INSULIN, FROM AN EXTERNAL INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on Dec 12, 2001. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Sterling Medivations, Inc. has 26 other 510(k) clearances on record.