K-number	K232118
Device name	ANDORATE® Valve Kit
Applicant	Ga Health Company Limited
Product code	ODC
Device class	Class II
Decision date	Oct 16, 2023
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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ANDORATE® Valve Kit

Everything you need for a 510(k) submission. Nothing you don't.