FDA 510(k) Application Details - K232477

Device Classification Name Pump, Breast, Powered

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510(K) Number K232477
Device Name Pump, Breast, Powered
Applicant Jiangxi AOV Maternity & Baby Products Co., Ltd.
8. Nanhuan Road, Industrial Park
Guixi 335400 CN
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Contact Huang Xueping
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Regulation Number 884.5160

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Classification Product Code HGX
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Date Received 08/16/2023
Decision Date 05/09/2024
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 K232477


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