K-number	K083300
Device name	GORE FLOW REVERSAL SYSTEM
Applicant	W. L. Gore & Associates, Inc.
Product code	NTE
Device class	Class II
Decision date	Feb 4, 2009
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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GORE FLOW REVERSAL SYSTEM

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