K-number	K063546
Device name	INSUFLOW DEVICE, MODEL 6198
Applicant	Lexion Medical, LLC
Product code	HIF
Device class	Class II
Decision date	Jan 10, 2007
Decision	Substantially Equivalent
Regulation	884.1730

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View the full FDA submission: accessdata.fda.gov

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INSUFLOW DEVICE, MODEL 6198

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