Electric Breast Pump

Pump, Breast, Powered

Joytech Healthcare Co., Ltd.

The following data is part of a premarket notification filed by Joytech Healthcare Co., Ltd. with the FDA for Electric Breast Pump.

Pre-market Notification Details

Device IDK172989
510k NumberK172989
Device Name:Electric Breast Pump
ClassificationPump, Breast, Powered
Applicant Joytech Healthcare Co., Ltd. No.365, Wuzhou Road, Yuhang Economic Development Zone Hangzhou City Hangzhou,  CN 311100
ContactRen Yunhua
CorrespondentRen Yunhua
Joytech Healthcare Co., Ltd. No.365, Wuzhou Road, Yuhang Economic Development Zone Hangzhou City Hangzhou,  CN 311100
Product CodeHGX  
CFR Regulation Number884.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-27
Decision Date2017-12-20
Summary:summary

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