K-number	K210562
Device name	HRSpheres Narrow-Size Embolic Microspheres
Applicant	Suzhou Hengrui Hongyuan Medical Co., Ltd.
Product code	KRD
Device class	Class II
Decision date	Oct 1, 2021
Decision	Substantially Equivalent
Regulation	870.3300

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Source

View the full FDA submission: accessdata.fda.gov

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HRSpheres Narrow-Size Embolic Microspheres

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