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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 K211755
Device Name Electric Breast Pump
Applicant
Zhejiang Carebao Co., Ltd.
3, No.1, Chuangye 4th Road, Ningbo Free Trade Zone
Ningbo,  CN 315000
Applicant Contact Yan Xie
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713A, Block A, Zhongguan Times Square, Liuxian Avenue
Xili Town
Shenzhen,  CN 518000
Correspondent Contact Iris Wang
Regulation Number884.5160
Classification Product Code
HGX  
Date Received06/07/2021
Decision Date 12/01/2021
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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