Electric Breast Pump

Pump, Breast, Powered

SHANTOU XINGHE ELECTRICAL APPARATUSES CO., LTD

The following data is part of a premarket notification filed by Shantou Xinghe Electrical Apparatuses Co., Ltd with the FDA for Electric Breast Pump.

Pre-market Notification Details

Device IDK143585
510k NumberK143585
Device Name:Electric Breast Pump
ClassificationPump, Breast, Powered
Applicant SHANTOU XINGHE ELECTRICAL APPARATUSES CO., LTD NO.8, YI ROAD, PINGBEI INDUSTRIAL ZONE CHAOYANG DISTRICT Shantou, Guangdong,  CN 515100
ContactJun Deng
CorrespondentMike Gu
Guangzhou Osmunda Medical Device Technical Services., Ltd. 7th Floor, Jingui Business Building, No. 982 Congyun Rd., Baiyun District,  CN 510420
Product CodeHGX  
CFR Regulation Number884.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-18
Decision Date2015-05-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06975740360711 K143585 000
06975740369721 K143585 000
00810115233763 K143585 000
00810115233718 K143585 000
06940657902033 K143585 000
06940657902019 K143585 000
00694065790206 K143585 000

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