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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 K242850
Device Name Wearable breast pump (model W8)
Applicant
Shenzhen TPH Technology Co., Ltd.
Rm. 203, 2nd Floor,29th Bldg.,Lianchuang Technology Park
#21 Bulan Rd., Xialilang Cmty, Nanwan St., Longgang Dist
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 Cmty, Nanwan St., Longgang Dist
Shenzhen,  CN 518100
Correspondent Contact Peter Chen
Regulation Number884.5160
Classification Product Code
HGX  
Date Received09/20/2024
Decision Date 02/21/2025
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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