FDA 510(k) Application Details - K240536

Device Classification Name Pump, Breast, Powered

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510(K) Number K240536
Device Name Pump, Breast, Powered
Applicant Shenzhen TPH Technology Co., Ltd.
Room 203, 2nd floor,29th Building, Lianchuang Technology
Park, Nanwan, 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 02/26/2024
Decision Date 07/01/2024
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 K240536


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