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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 K212180
Device Name Wearable Breast Pump (Model S12)
Applicant
Shenzhen TPH Technology Co., Ltd.
Bulan Road, Nanwan Community, Longgang District
Shenzhen,  CN 518100
Applicant Contact Peter Chen
Correspondent
Shenzhen TPH Technology Co., Ltd.
Bulan Road, Nanwan Community, Longgang District
Shenzhen,  CN 518100
Correspondent Contact Peter Chen
Regulation Number884.5160
Classification Product Code
HGX  
Date Received07/12/2021
Decision Date 02/11/2022
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
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