K-number	K860296
Device name	HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES
Applicant	Physicians Surgeons Purchasing Group
Product code	FKQ
Device class	Class II
Decision date	Mar 4, 1986
Decision	Substantially Equivalent
Regulation	876.5820

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HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES

Everything you need for a 510(k) submission. Nothing you don't.