K-number	K042797
Device name	WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
Applicant	Gambro Renal Products
Product code	FIP
Device class	Class II
Decision date	Mar 9, 2005
Decision	Substantially Equivalent
Regulation	876.5665

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View the full FDA submission: accessdata.fda.gov

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WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

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