K-number	K151084
Device name	Well Lead Ureteral Access Sheath
Applicant	Well Lead Medical Co., Ltd.
Product code	FED
Device class	Class II
Decision date	Jan 7, 2016
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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Well Lead Ureteral Access Sheath

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