510(k) K961040

BLOOD PORT CAP, DIALYSATE PORT CAP, RED HARD PLASTIC by Dayspring Medical, Inc. — Product Code FJI

K961040 is an FDA 510(k) premarket notification submitted by Dayspring Medical, Inc. for the device "BLOOD PORT CAP, DIALYSATE PORT CAP, RED HARD PLASTIC". The FDA issued a decision of Substantially Equivalent on June 11, 1996. The device falls under product code FJI (Dialyzer, Capillary, Hollow Fiber), a Class II device regulated under 21 CFR 876.5820. Dayspring Medical, Inc. has at least 4 other 510(k) clearances on record.