K-number	K062435
Device name	REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS
Applicant	Spire Biomedical, Inc.
Product code	NFK
Device class	Class II
Decision date	Dec 5, 2006
Decision	Substantially Equivalent
Regulation	876.5540

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View the full FDA submission: accessdata.fda.gov

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REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS

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