K-number	K200173
Device name	Stone Retrieval Balloon
Applicant	Hangzhou AGS MedTech Co., Ltd.
Product code	GCA
Device class	Class II
Decision date	May 1, 2020
Decision	Substantially Equivalent
Regulation	876.5010

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Source

View the full FDA submission: accessdata.fda.gov

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Stone Retrieval Balloon

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