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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vascular, For Promoting Embolization
510(k) Number K210562
Device Name HRSpheres Narrow-Size Embolic Microspheres
Applicant
Suzhou Hengrui Hongyuan Medical Co., Ltd.
Bldg. B9 Unit 201, # 218 Xinghu Rd., Sip,
Suzhou,  CN 215123
Applicant Contact Qianqian Zhang
Correspondent
Suzhou Hengrui Hongyuan Medical Co., Ltd.
Bldg. B9 Unit 201, # 218 Xinghu Rd., Sip,
Suzhou,  CN 215123
Correspondent Contact Qianqian Zhang
Regulation Number870.3300
Classification Product Code
KRD  
Subsequent Product Code
NAJ  
Date Received02/25/2021
Decision Date 10/01/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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