K-number	K080650
Device name	OMNI-DL SYSTEM
Applicant	Transvivo, Inc.
Product code	KDI
Device class	Class II
Decision date	Nov 26, 2008
Decision	Substantially Equivalent
Regulation	876.5860

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Source

View the full FDA submission: accessdata.fda.gov

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OMNI-DL SYSTEM

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