K-number	K002457
Device name	!NSURE FECAL OCCULT BLOOD TEST
Applicant	Enterix, Inc.
Product code	KHE
Device class	Class II
Decision date	Jan 12, 2001
Decision	Substantially Equivalent
Regulation	864.6550

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View the full FDA submission: accessdata.fda.gov

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!NSURE FECAL OCCULT BLOOD TEST

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