K-number	K042938
Device name	GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS
Applicant	Gambro Renal Products
Product code	KDI
Device class	Class II
Decision date	Jan 6, 2005
Decision	Substantially Equivalent
Regulation	876.5860

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View the full FDA submission: accessdata.fda.gov

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GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS

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