K-number	K080117
Device name	PATIENT ISOLATION UNIT, MODEL G019-1000
Applicant	Gentex Corporation
Product code	LGM
Device class	Class II
Decision date	Jan 30, 2009
Decision	Substantially Equivalent
Regulation	880.5450

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View the full FDA submission: accessdata.fda.gov

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PATIENT ISOLATION UNIT, MODEL G019-1000

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