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FDA 510(k) Application Details - K232477
Device Classification Name
Pump, Breast, Powered
More FDA Info for this Device
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
Other 510(k) Applications for this Company
Contact
Huang Xueping
Other 510(k) Applications for this Contact
Regulation Number
884.5160
More FDA Info for this Regulation Number
Classification Product Code
HGX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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