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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 K162747
Device Name Proture Double Electric Breast Pump
Applicant
Guangdong Horigen Mother & Baby Products Co., Ltd.
#8, Yi Rd., Pingbei Industrial Zone, Chaoyang District
Shantou,  CN 515100
Applicant Contact Jun Deng
Correspondent
Giangzhou Osmunda Medical Device Technical Service Co., Ltd.
8-9th Floor, R&D Bldg., #26 Qinglan St., Panyu
District
Guangzhou,  CN 510006
Correspondent Contact Mike Gu
Regulation Number884.5160
Classification Product Code
HGX  
Date Received09/30/2016
Decision Date 12/08/2016
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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