K-number	K191252
Device name	Gem FlowCoupler System
Applicant	Baxter/ Synovis Micro Companies Alliance, Inc.
Product code	MVR
Device class	Class II
Decision date	Jul 9, 2019
Decision	Substantially Equivalent
Regulation	878.4300

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Source

View the full FDA submission: accessdata.fda.gov

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Gem FlowCoupler System

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