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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 K203148
Device Name Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030); Bebebao Electric Breast Pump (Model: BB-5020); Yiyadodo Electric Breast Pump (Model: YY-5030)
Applicant
Ningbo Youhe Electrical Appliance Technology Co., Ltd.
No.567, Xintang Road, Fuhai 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 200240
Correspondent Contact Daniel Qiu
Regulation Number884.5160
Classification Product Code
HGX  
Date Received10/22/2020
Decision Date 07/08/2021
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
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