K-number	K202134
Device name	Well Lead All Silicone Foley Catheter with Temperature Sensor
Applicant	Well Lead Medical Co., Ltd.
Product code	EZL
Device class	Class II
Decision date	Apr 8, 2021
Decision	Substantially Equivalent
Regulation	876.5130

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Source

View the full FDA submission: accessdata.fda.gov

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Well Lead All Silicone Foley Catheter with Temperature Sensor

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