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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 K240218
Device Name Electric Breast Pump (F5055)
Applicant
Fimilla (Shanghai) maternity & baby Articles Co., Ltd
No. 65 Lane 3029 HuaXu Road HuaXin Town QingPu District
Shanghai,  CN
Applicant Contact Jason Liu
Correspondent
Mid-Link Consulting Co., Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number884.5160
Classification Product Code
HGX  
Date Received01/26/2024
Decision Date 10/17/2024
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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