K-number	K091516
Device name	WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR
Applicant	Well Lead Medical Co., Ltd.
Product code	EZL
Device class	Class II
Decision date	Oct 16, 2009
Decision	Substantially Equivalent
Regulation	876.5130

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View the full FDA submission: accessdata.fda.gov

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WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR

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