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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 K260346
Device Name Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)
Applicant
Polybell (Guangzhou) Limited
# 50, W. St., Xihu Village, Renhe Town
Baiyun District
Guangzhou,  CN 510470
Applicant Contact Qingliang Xu
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center, # 3101-90
Qinahai Rd.
Shenzhen,  CN 518052
Correspondent Contact Axiu Yang
Regulation Number884.5160
Classification Product Code
HGX  
Date Received02/03/2026
Decision Date 06/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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