K-number	K945136
Device name	RENAGUARD DIALYSATE FILTER
Applicant	Minntech Corp.
Product code	FIP
Device class	Class II
Decision date	Feb 28, 1995
Decision	Substantially Equivalent
Regulation	876.5665

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Source

View the full FDA submission: accessdata.fda.gov

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RENAGUARD DIALYSATE FILTER

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