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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 K202802
Device Name TT Electric Breast Pump, TT Double Electric Breast Pump
Applicant
Wuxi Xinzhongrui Baby Supplies Co., Ltd.
No. 117 Xinhua Road, Meicun, New Wu District,
Wuxi,  CN 214000
Applicant Contact Zhang Chunyan
Correspondent
Shanghai Landlink Medical Information Technology Co., Ltd.
Room 703, 705, Building 1, West Guangzhong Road 555, Jingan
District
Shanghai,  CN 200071
Correspondent Contact Shelley Li
Regulation Number884.5160
Classification Product Code
HGX  
Date Received09/23/2020
Decision Date 08/26/2021
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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