K-number	K220722
Device name	PVC Hydrophilic Urethral Catheter
Applicant	Well Lead Medical Co., Ltd.
Product code	EZD
Device class	Class II
Decision date	May 22, 2023
Decision	Substantially Equivalent
Regulation	876.5130

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Source

View the full FDA submission: accessdata.fda.gov

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PVC Hydrophilic Urethral Catheter

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