Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)

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 (model Kp033_01), Electric Double Breast Pump (model Kp053_01).

Pre-market Notification Details

Device IDK193449
510k NumberK193449
Device Name:Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)
ClassificationPump, Breast, Powered
Applicant Guangdong Horigen Mother & Baby Products Co., Ltd No. 18, Pingnan Industrial Zone, Mianbei Street, Chaoyang District Shantou,  CN 515100
ContactJun Deng
CorrespondentJun Deng
Guangdong Horigen Mother & Baby Products Co., Ltd No. 18, Pingnan Industrial Zone, Mianbei Street, Chaoyang District Shantou,  CN 515100
Product CodeHGX  
CFR Regulation Number884.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-13
Decision Date2020-09-11

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