510(k) K043304

Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01 by Bioject Medical Technologies, Inc. — Product Code LHI

K043304 is an FDA 510(k) premarket notification submitted by Bioject Medical Technologies, Inc. for the device "Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01". The FDA issued a decision of Substantially Equivalent on January 14, 2005. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Bioject Medical Technologies, Inc. has at least 2 other 510(k) clearances on record.