K-number	K201741
Device name	Gabriel 3 Way EnFit Valve
Applicant	Syncro Medical Innovations, Inc.
Product code	PIF
Device class	Class II
Decision date	Nov 5, 2020
Decision	Substantially Equivalent
Regulation	876.5980

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Source

View the full FDA submission: accessdata.fda.gov

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Gabriel 3 Way EnFit Valve

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