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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 K223329
Device Name Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201)
Applicant
Guangzhou Yongyi Industrial Co., Ltd.
# 4, Majun Rd., Dongchong Town, Nansha District
Guangzhou,  CN 523000
Applicant Contact Wei Hu
Correspondent
Guangzhou Glomed Biologcial Technology Co., Ltd.
2231, Bldg. 1, Rui Feng Center, Kaichuang Rd.
Huangpu District
Guangzhou,  CN 523000
Correspondent Contact Cassie Lee
Regulation Number884.5160
Classification Product Code
HGX  
Date Received10/31/2022
Decision Date 05/26/2023
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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