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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 K251977
Device Name electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)
Applicant
Ningbo Youhe Electrical Appliance Technology Co., Ltd.
567# Xintang Rd., Fuhai Town
Cixi,  CN 315322
Applicant Contact Haifeng Hua
Correspondent
Huaxiajiamei (Beijing) Information Consulting Co.,Ltd
B2 Floor, Zhongguancun Dongsheng Science And Technology Park
# 66 Xixiaolu Rd., Haidian District
Beijing,  CN 100192
Correspondent Contact Linda Li
Regulation Number884.5160
Classification Product Code
HGX  
Date Received06/27/2025
Decision Date 10/22/2025
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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