K-number	K202838
Device name	Andorate Universal Endoscope Tip Guard
Applicant	Ga Health Company Limited
Product code	OCU
Device class	Class II
Decision date	Mar 5, 2021
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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Andorate Universal Endoscope Tip Guard

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