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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 K163136
Device Name Youha electric breast pump
Applicant
NINGBO YOUHE ELECTRICAL APPLIANCE TECHNOLOGY CO.,LTD.
NO.226-228, SAN JIAO TIAN RD, FU HAI TOWN
CIXI,  CN 315322
Applicant Contact Huang Yun Jun
Correspondent
SHANGHAI QISHENG BUSINESS CONSULTING CO.,LTD.
ROOM 1301, BLD 46, JING GU ZHONG RD., NO.58,
MIN HANG DISTRICT, SHANGHAI, CN
Shanghai,  CN 200240
Correspondent Contact Daniel Qiu
Regulation Number884.5160
Classification Product Code
HGX  
Date Received11/08/2016
Decision Date 07/31/2017
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
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