FDA 510(k) Application Details - K232466

Device Classification Name Pump, Breast, Powered

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510(K) Number K232466
Device Name Pump, Breast, Powered
Applicant Guangdong Youmeng Electrical Technology Co., Ltd.
One of Area A, level 3, Building 2, No. 17, Keyuan 3rd Road
Shunde Hi Tech Industrial Park, Xiaoh
Foshan 528303 CN
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Contact Liu Zongjun
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Regulation Number 884.5160

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Classification Product Code HGX
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Date Received 08/15/2023
Decision Date 01/19/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K232466


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