510(k) K843639

ADD-A-VIAL SOLUTION TRANSFER DEVICE by American Mcgaw — Product Code LHI

K843639 is an FDA 510(k) premarket notification submitted by American Mcgaw for the device "ADD-A-VIAL SOLUTION TRANSFER DEVICE". The FDA issued a decision of Substantially Equivalent on January 14, 1985. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. American Mcgaw has at least 10 other 510(k) clearances on record.