510(k) K023539

STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSFLOW by Valumed — Product Code LHI

K023539 is an FDA 510(k) premarket notification submitted by Valumed for the device "STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSFLOW". The FDA issued a decision of Substantially Equivalent on December 17, 2002. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Valumed has at least 1 other 510(k) clearance on record.