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510(k) K210562

HRSpheres Narrow-Size Embolic Microspheres by Suzhou Hengrui Hongyuan Medical Co., Ltd. — Product Code KRD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 2021
Date Received
February 25, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Vascular, For Promoting Embolization
Device Class
Class II
Regulation Number
870.3300
Review Panel
CV
Submission Type

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