510(k) K972728

STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS) by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code FMF

K972728 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS)". The FDA issued a decision of Substantially Equivalent on July 15, 1998. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.