K-number	K181445
Device name	AMSure Hydrophilic Intermittent Catheter
Applicant	Amsino International, Inc.
Product code	EZD
Device class	Class II
Decision date	Oct 1, 2018
Decision	Substantially Equivalent
Regulation	876.5130

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Source

View the full FDA submission: accessdata.fda.gov

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AMSure Hydrophilic Intermittent Catheter

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