K-number	K213283
Device name	GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter
Applicant	Convatec Limited
Product code	GBM
Device class	Class II
Decision date	Jun 22, 2022
Decision	Substantially Equivalent
Regulation	876.5130

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View the full FDA submission: accessdata.fda.gov

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GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter

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