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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 K222045
Device Name Wearable Breast Pump (Model S1DW)
Applicant
Shenzhen Tph Technology Co., Ltd.
5th Floor, Bldg. #29 Eastside
Lianchuang 2nd Technology Park, Longgang District
Shenzhen,  CN 518100
Applicant Contact Peter Chen
Correspondent
Shenzhen Joyantech Consulting Co. , Ltd.
1713a, 17th Floor, Block A, Zhongguan Times Square
Liuxian Ave., Xili Town, Nanshan District,
Shenzhen,  CN 518000
Correspondent Contact Carmen Zhang
Regulation Number884.5160
Classification Product Code
HGX  
Date Received07/11/2022
Decision Date 01/04/2023
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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