510(k) K961039

BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYL by Dayspring Medical, Inc. — Product Code FJI

K961039 is an FDA 510(k) premarket notification submitted by Dayspring Medical, Inc. for the device "BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYL". The FDA issued a decision of Substantially Equivalent on September 12, 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.