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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Breast, Powered
510(k) Number K211024
Device Name Electric Breast Pump
Applicant
Shantou Huihengqi Electronic Technology Co., Ltd.
501, 5/F, Block C, 14a Industrial Zone, Longhu District
Shantou,  CN 515000
Applicant Contact Gensong Yang
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119, Shanghai
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number884.5160
Classification Product Code
HGX  
Date Received04/06/2021
Decision Date 02/11/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
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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