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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 K151284
Device Name Electric Double Breast Pumps
Applicant
Wuxi Xinzhongrui Baby Supplies Co.,Ltd
NO.117 XINHUA ROAD, MEICUN, NEW DISTRICT
WUXI,  CN 214115
Applicant Contact Shaozhong Chen
Correspondent
Mid-Link Consulting Co.,Ltd
P.O.Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number884.5160
Classification Product Code
HGX  
Date Received05/14/2015
Decision Date 12/21/2015
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
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