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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 K250350
Device Name Thrive 2-in-1 Breast Pump (Model P3)
Applicant
Shenzhen TPH Technology Co., Ltd.
Rm. 203, 2nd Floor, 29th Bldg., Lianchuang Technology
Park, #21 Bulan Rd., Xialilang
Shenzhen,  CN 518100
Applicant Contact Yang Xiaoyan
Correspondent
Shenzhen TPH Technology Co., Ltd.
Rm. 203, 2nd Floor, 29th Bldg., Lianchuang Technology
Park, #21 Bulan Rd., Xialilang
Shenzhen,  CN 518100
Correspondent Contact Yang Xiaoyan
Regulation Number884.5160
Classification Product Code
HGX  
Date Received02/07/2025
Decision Date 07/15/2025
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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