510(k) K862840

GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N by Gambro, Inc. — Product Code FJG

K862840 is an FDA 510(k) premarket notification submitted by Gambro, Inc. for the device "GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N". The FDA issued a decision of Substantially Equivalent on September 29, 1986. The device falls under product code FJG (Dialyzer, Parallel Flow), a Class II device regulated under 21 CFR 876.5820. Gambro, Inc. has at least 10 other 510(k) clearances on record.