K-number	K161410
Device name	VT·One, VT·One 60days
Applicant	Carilex Medical, Inc.
Product code	OMP
Device class	Class II
Decision date	Oct 13, 2016
Decision	Substantially Equivalent
Regulation	878.4780

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Source

View the full FDA submission: accessdata.fda.gov

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VT·One, VT·One 60days

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