FDA 510(k) Application Details - K223886

Device Classification Name Pump, Breast, Powered

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510(K) Number K223886
Device Name Pump, Breast, Powered
Applicant Shenzhen TPH Technology Co., Ltd.
5th floor,Lianchuang 2nd technology Park, Bulan Road
Nanwan Community,Longgang District
Shenzhen 518100 CN
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Contact Peter Chen
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Regulation Number 884.5160

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Classification Product Code HGX
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Date Received 12/27/2022
Decision Date 07/14/2023
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



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