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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Breast, Powered
510(k) Number K193449
Device Name Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)
Applicant
Guangdong Horigen Mother & Baby Products Co., Ltd.
# 18, Pingnan Industrial Zone, Mianbei St.
Chaoyang District
Shantou,  CN 515100
Applicant Contact Jun Deng
Correspondent
Guangdong Horigen Mother & Baby Products Co., Ltd.
# 18, Pingnan Industrial Zone, Mianbei St.
Chaoyang District
Shantou,  CN 515100
Correspondent Contact Jun Deng
Regulation Number884.5160
Classification Product Code
HGX  
Date Received12/13/2019
Decision Date 09/11/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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