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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 K150923
Device Name Breast Pump
Applicant
Guangzhou Jinxinbao Electronic Co., Ltd.
#38 Huanzhen Xi Rd.,
Dagang Town, Nansha
Guangzhou,Guangdong,  CN 511470
Applicant Contact Jiacheng Guo
Correspondent
Wenzhou Cytech Information Service Co., Ltd.
Rm.302, #21 Bldg., Kaiyu Garden, Xishan S. Rd.
Wenzhou, Zhejiang,  CN 325000
Correspondent Contact Helen Nan
Regulation Number884.5160
Classification Product Code
HGX  
Subsequent Product Code
BSY  
Date Received04/06/2015
Decision Date 11/06/2015
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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