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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 K261298
Device Name Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))
Applicant
Guangdong Youmeng Electrical Technology Co., Ltd.
One Of Area A, Level 3, Bldg. 2, # 17, Keyuan 3rd Rd., Xiaoh
Foshan,  CN 528303
Applicant Contact Zhongjun Liu
Correspondent
ABMED Medical Technology PTY, Ltd.
48/6 Herbert St.
St Leonards,  AU 2065
Correspondent Contact Boyle Wang
Regulation Number884.5160
Classification Product Code
HGX  
Date Received04/20/2026
Decision Date 08/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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