510(k) K011982

0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE by Bd — Product Code FOZ

K011982 is an FDA 510(k) premarket notification submitted by Bd for the device "0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE". The FDA issued a decision of Substantially Equivalent on July 17, 2001. 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. Bd has at least 10 other 510(k) clearances on record.