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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 K201903
Device Name Electric breast pump (Models: RH-228 and RH-338)
Applicant
Cixi Ruihong Electric Appliance Co., Ltd.
# 18, Xiamaojia Rd., Shuangqingpu Village, Xinpu Town,
Cixi
Ningbo,  CN 315322
Applicant Contact Zhangkelong Zhangkelong
Correspondent
Cixi Ruihong Electric Appliance Co., Ltd.
# 18, Xiamaojia Rd., Shuangqingpu Village, Xinpu Town,
Cixi
Ningbo,  CN 315322
Correspondent Contact Kelong Zhang
Regulation Number884.5160
Classification Product Code
HGX  
Date Received07/08/2020
Decision Date 04/09/2021
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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