K-number	K041005
Device name	GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS
Applicant	Gambro Renal Products
Product code	KDI
Device class	Class II
Decision date	Oct 7, 2004
Decision	Substantially Equivalent
Regulation	876.5860

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View the full FDA submission: accessdata.fda.gov

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GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS

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