510(k) K974431

CHEMO-SPIKE II RECONSTITUTION DEVICE by Medi-Dose, Inc. — Product Code LHI

K974431 is an FDA 510(k) premarket notification submitted by Medi-Dose, Inc. for the device "CHEMO-SPIKE II RECONSTITUTION DEVICE". The FDA issued a decision of Substantially Equivalent on Jan 8, 1998. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Medi-Dose, Inc. has at least 3 other 510(k) clearances on record.