510(k) K972134

BAG DECANTER by Remington Medical, Inc. — Product Code LHI

K972134 is an FDA 510(k) premarket notification submitted by Remington Medical, Inc. for the device "BAG DECANTER". The FDA issued a decision of Substantially Equivalent on August 26, 1997. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Remington Medical, Inc. has at least 10 other 510(k) clearances on record.