510(k) K992732

STERILE WATER & STERILE 0.9% SODIUM CHLORIDE by Dumex Medical Surgical Products, Ltd. — Product Code FOZ

K992732 is an FDA 510(k) premarket notification submitted by Dumex Medical Surgical Products, Ltd. for the device "STERILE WATER & STERILE 0.9% SODIUM CHLORIDE". The FDA issued a decision of Substantially Equivalent on April 20, 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. Dumex Medical Surgical Products, Ltd. has at least 10 other 510(k) clearances on record.