510(k) K843504

AMER. BENTLEY HEMOFILTER HOLDER HFH-1 by American Bentley — Product Code FKI

K843504 is an FDA 510(k) premarket notification submitted by American Bentley for the device "AMER. BENTLEY HEMOFILTER HOLDER HFH-1". The FDA issued a decision of Substantially Equivalent on October 18, 1984. The device falls under product code FKI (Set, Dialyzer Holder), a Class II device regulated under 21 CFR 876.5820. American Bentley has at least 10 other 510(k) clearances on record.