510(k) K902588

BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VEN PRESS MOD by Gambro-Hospal, Inc. — Product Code KOC

K902588 is an FDA 510(k) premarket notification submitted by Gambro-Hospal, Inc. for the device "BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VEN PRESS MOD". The FDA issued a decision of Substantially Equivalent on March 7, 1991. The device falls under product code KOC (Accessories, Blood Circuit, Hemodialysis), a Class II device regulated under 21 CFR 876.5820. Gambro-Hospal, Inc. has at least 2 other 510(k) clearances on record.