TT Electric Breast Pump, TT Double Electric Breast Pump

Pump, Breast, Powered

Wuxi Xinzhongrui Baby Supplies Co., Ltd.

The following data is part of a premarket notification filed by Wuxi Xinzhongrui Baby Supplies Co., Ltd. with the FDA for Tt Electric Breast Pump, Tt Double Electric Breast Pump.

Pre-market Notification Details

Device IDK202802
510k NumberK202802
Device Name:TT Electric Breast Pump, TT Double Electric Breast Pump
ClassificationPump, Breast, Powered
Applicant Wuxi Xinzhongrui Baby Supplies Co., Ltd. No. 117 Xinhua Road, Meicun, New Wu District, Wuxi,  CN 214000
ContactZhang Chunyan
CorrespondentShelley Li
Shanghai Landlink Medical Information Technology Co., Ltd. Room 703, 705, Building 1, West Guangzhong Road 555, Jingan District Shanghai,  CN 200071
Product CodeHGX  
CFR Regulation Number884.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-23
Decision Date2021-08-26

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