Name: Predicase
Price: 199 USD

K-number	K023985
Device name	ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAINING DI-ACETATE
Applicant	Rockwell Medical Technologies, Inc.
Product code	KPO
Device class	Class II
Decision date	Feb 28, 2003
Decision	Substantially Equivalent
Regulation	876.5820

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Source

View the full FDA submission: accessdata.fda.gov

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ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAINING DI-ACETATE

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