K-number	K132727
Device name	GEM FLOW COUPLER DEVICE AND SYSTEM
Applicant	Synovis Life Technologies, Inc.
Product code	MVR
Device class	Class II
Decision date	Oct 22, 2013
Decision	Substantially Equivalent
Regulation	878.4300

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Source

View the full FDA submission: accessdata.fda.gov

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GEM FLOW COUPLER DEVICE AND SYSTEM

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