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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 K142479
Device Name MEGNA BREAST PUMPS
Applicant
Wuxi Xinzhongrui Baby Supplies Co., Ltd.
#117 Xinhua Rd., Meicun, New District
Wuxi City,  CN 214000
Applicant Contact ANNE CHEN
Correspondent
Megna, Inc.
1043 Andrew Dr.
West Chester,  PA  19380
Correspondent Contact DAVID ZENG
Regulation Number884.5160
Classification Product Code
HGX  
Date Received09/04/2014
Decision Date 02/24/2015
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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