510(k) K050339

SET GRI-FILL 3.0-1 WAY, 2 WAYS, MULTIPLE by Laboratorios Grifols, S.A. — Product Code LHI

K050339 is an FDA 510(k) premarket notification submitted by Laboratorios Grifols, S.A. for the device "SET GRI-FILL 3.0-1 WAY, 2 WAYS, MULTIPLE". The FDA issued a decision of Substantially Equivalent on Feb 25, 2005. 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.