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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 K243508
Device Name Wearable breast pump (model S12A)
Applicant
Shenzhen TPH Technology Co., Ltd.
Rm. 203, 2nd Floor, 29th Bldg., Lianchuang Technology
Park, #21 Bulan Rd., Xialilang Community, Nanwan St.,
Shenzhen,  CN 518100
Applicant Contact Peter Chen
Correspondent
Shenzhen TPH Technology Co., Ltd.
Rm. 203, 2nd Floor, 29th Bldg., Lianchuang Technology
Park, #21 Bulan Rd., Xialilang Community, Nanwan St.,
Shenzhen,  CN 518100
Correspondent Contact Peter Chen
Regulation Number884.5160
Classification Product Code
HGX  
Date Received11/12/2024
Decision Date 04/21/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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