K-number	K101831
Device name	ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800
Applicant	Bionostics, Inc.
Product code	OSL
Device class	Class II
Decision date	Oct 1, 2010
Decision	Substantially Equivalent
Regulation	864.6550

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View the full FDA submission: accessdata.fda.gov

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ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800

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