510(k) K023827

PARAGON INFUSION SYSTEM WITH BOLUS by I-Flow Corp. — Product Code FRN

K023827 is an FDA 510(k) premarket notification submitted by I-Flow Corp. for the device "PARAGON INFUSION SYSTEM WITH BOLUS". The FDA issued a decision of Substantially Equivalent on December 13, 2002. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. I-Flow Corp. has at least 10 other 510(k) clearances on record.