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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 K231969
Device Name BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808)
Applicant
Dongguanshi Yiyingmei Technology Co., Ltd.
Room 701, No. 31 Tangxi Street Shatou, Chang'an Town
Donguang,  CN 523000
Applicant Contact Chen Jian
Correspondent
Dongguanshi Yiyingmei Technology Co., Ltd.
Room 701, No. 31 Tangxi Street Shatou, Chang'an Town
Donguang,  CN 523000
Correspondent Contact Chen Jian
Regulation Number884.5160
Classification Product Code
HGX  
Date Received07/03/2023
Decision Date 08/30/2024
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
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