K-number	K241442
Device name	eZSURE Empty Fluid Container with ProSeal Injection Site
Applicant	Epic Medical Pte. , Ltd.
Product code	KPE
Device class	Class II
Decision date	Jun 21, 2024
Decision	Substantially Equivalent
Regulation	880.5025

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Source

View the full FDA submission: accessdata.fda.gov

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eZSURE Empty Fluid Container with ProSeal Injection Site

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eZSURE Empty Fluid Container with ProSeal Injection Site