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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 K252192
Device Name Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25)
Applicant
Huizhou Lvb Maternal and Infant Supplies Co., Ltd.
# 114,Xin Xing N. Rd., Sandong Town, Huicheng District
Huizhou,  CN 516000
Applicant Contact Zhang Dongan
Correspondent
Huizhou Lvb Maternal and Infant Supplies Co., Ltd.
# 114,Xin Xing N. Rd., Sandong Town, Huicheng District
Huizhou,  CN 516000
Correspondent Contact Zhang Dongan
Regulation Number884.5160
Classification Product Code
HGX  
Date Received07/14/2025
Decision Date 08/13/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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