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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 K254125
Device Name Electric Breast Pump (HL-3058 II Pro)
Applicant
Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.
# 65 Ln. 3029 Huaxu Rd., Huaxin Town Qingpu District
Shanghai,  CN 201700
Applicant Contact Shulin Wu
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center, # 3101-90, Qia
Shenzhen,  CN 518052
Correspondent Contact Youshan Gong
Regulation Number884.5160
Classification Product Code
HGX  
Date Received12/19/2025
Decision Date 05/13/2026
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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