K-number	K003123
Device name	RENAX A.V. FISTULA NEEDLE SETS
Applicant	Sunder Biomedical Tech. Co., Ltd.
Product code	FIE
Device class	Class II
Decision date	May 4, 2001
Decision	Substantially Equivalent
Regulation	876.5540

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View the full FDA submission: accessdata.fda.gov

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RENAX A.V. FISTULA NEEDLE SETS

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