Electric Breast Pump

Pump, Breast, Powered

Guangdong Horigen Mother & Baby Products Co., Ltd.

The following data is part of a premarket notification filed by Guangdong Horigen Mother & Baby Products Co., Ltd. with the FDA for Electric Breast Pump.

Pre-market Notification Details

Device IDK212564
510k NumberK212564
Device Name:Electric Breast Pump
ClassificationPump, Breast, Powered
Applicant Guangdong Horigen Mother & Baby Products Co., Ltd. No. 18, Pingnan Industrial Zone, Mianbei Street Chaoyang District Shantou,  CN 515100
ContactChangxin Chen
CorrespondentOlivia Meng
Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9th Floor, R&D Building, No.26 Qinglan Street, Panyu Distr Guangzhou,  CN 510006
Product CodeHGX  
CFR Regulation Number884.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-13
Decision Date2022-05-06

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