510(k) K020996

MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL by Medefil, Inc. — Product Code NGT

K020996 is an FDA 510(k) premarket notification submitted by Medefil, Inc. for the device "MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL". The FDA issued a decision of Substantially Equivalent on June 24, 2002. The device falls under product code NGT (Saline, Vascular Access Flush), a Class II device regulated under 21 CFR 880.5200. Medefil, Inc. has at least 6 other 510(k) clearances on record.