K-number	K162640
Device name	iVitri EZ
Applicant	Reprobitech Corp.
Product code	MQK
Device class	Class II
Decision date	Jun 30, 2017
Decision	Substantially Equivalent
Regulation	884.6160

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Source

View the full FDA submission: accessdata.fda.gov

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iVitri EZ

Everything you need for a 510(k) submission. Nothing you don't.