510(k) K022053

HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134 by Sebia — Product Code JHO

K022053 is an FDA 510(k) premarket notification submitted by Sebia for the device "HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134". The FDA issued a decision of Substantially Equivalent on July 12, 2002. The device falls under product code JHO (Electrophoretic Separation, Lipoproteins), a Class I device regulated under 21 CFR 862.1475. Sebia has at least 10 other 510(k) clearances on record.