K-number	K221401
Device name	Self-Cath and Self-Cath Plus
Applicant	Coloplast
Product code	EZD
Device class	Class II
Decision date	Dec 2, 2022
Decision	Substantially Equivalent
Regulation	876.5130

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Source

View the full FDA submission: accessdata.fda.gov

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Self-Cath and Self-Cath Plus

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