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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 K143585
Device Name Electric Breast Pump
Applicant
Shantou Xinghe Electrical Apparatuses Co., Ltd.
#8, Yi Rd., Pingbei Industrial Zone
Chaoyang District
Shantou, Guangdong,  CN 515100
Applicant Contact Jun Deng
Correspondent
Guangzhou Osmunda Medical Device Technical Services., Ltd.
7th Floor, Jingui Business Bldg., # 982 Congyun Rd.,
Baiyun District,  CN 510420
Correspondent Contact Mike Gu
Regulation Number884.5160
Classification Product Code
HGX  
Date Received12/18/2014
Decision Date 05/06/2015
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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