510(k) K841307

BBL GASPAK POUCH by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code FKJ

K841307 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "BBL GASPAK POUCH". The FDA issued a decision of Substantially Equivalent on May 14, 1984. The device falls under product code FKJ (Filter, Blood, Dialysis), a Class II device regulated under 21 CFR 876.5820. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.