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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 K220596
Device Name Wearable Breast Pump (Model S9)
Applicant
Shenzhen TPH Technology Co., Ltd.
5th floor, Lianchuang 2nd technology Park,
Bulan Road, Nanwan Community, Longgang District
Shenzhen,  CN 518100
Applicant Contact Peter Chen
Correspondent
Shenzhen TPH Technology Co., Ltd.
5th floor, Lianchuang 2nd technology Park,
Bulan Road, Nanwan Community, Longgang District
Shenzhen,  CN 518100
Correspondent Contact Peter Chen
Regulation Number884.5160
Classification Product Code
HGX  
Date Received03/01/2022
Decision Date 05/26/2022
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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