K-number	K090879
Device name	INSUFLOW CO2IONSHIELD
Applicant	Lexion Medical, LLC
Product code	FCX
Device class	Class II
Decision date	Jul 23, 2009
Decision	Substantially Equivalent
Regulation	876.1500

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View the full FDA submission: accessdata.fda.gov

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INSUFLOW CO2IONSHIELD

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