K-number	K173533
Device name	Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter
Applicant	Poiesis Medical, LLC
Product code	EZL
Device class	Class II
Decision date	Mar 29, 2018
Decision	Substantially Equivalent
Regulation	876.5130

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Source

View the full FDA submission: accessdata.fda.gov

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Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter

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