K-number	K023162
Device name	FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS
Applicant	Fresenius Medical Care
Product code	FIE
Device class	Class II
Decision date	Mar 20, 2003
Decision	Substantially Equivalent
Regulation	876.5540

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View the full FDA submission: accessdata.fda.gov

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FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS

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