510(k) K993515

MEDEFIL'S NORMAL SALINE FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE L by Medefil, Inc. — Product Code FOZ

K993515 is an FDA 510(k) premarket notification submitted by Medefil, Inc. for the device "MEDEFIL'S NORMAL SALINE FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE L". The FDA issued a decision of Substantially Equivalent on February 25, 2000. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Medefil, Inc. has at least 6 other 510(k) clearances on record.