K-number	K230280
Device name	ANDORATE® Suction Valve and ANDORATE® Biopsy Valve
Applicant	Ga Health Company Limited
Product code	KTI
Device class	Class II
Decision date	May 11, 2023
Decision	Substantially Equivalent
Regulation	874.4680

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Source

View the full FDA submission: accessdata.fda.gov

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ANDORATE® Suction Valve and ANDORATE® Biopsy Valve

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