K-number	K993806
Device name	DIALGUARD ENDOTOXIN REMOVAL DEVICE
Applicant	Clarigen, Inc.
Product code	FIP
Device class	Class II
Decision date	Aug 14, 2000
Decision	Substantially Equivalent
Regulation	876.5665

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View the full FDA submission: accessdata.fda.gov

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DIALGUARD ENDOTOXIN REMOVAL DEVICE

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