510(k) K033682

SET GRI-FILL 2.0-1 WAY; 2.0-2 WAYS; LUER CONNECTION TUBE by Laboratorios Grifols, S.A. — Product Code LHI

K033682 is an FDA 510(k) premarket notification submitted by Laboratorios Grifols, S.A. for the device "SET GRI-FILL 2.0-1 WAY; 2.0-2 WAYS; LUER CONNECTION TUBE". The FDA issued a decision of Substantially Equivalent on Dec 17, 2003. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Laboratorios Grifols, S.A. has 8 other 510(k) clearances on record.