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FDA 510(k) Application Details - K211024
Device Classification Name
Pump, Breast, Powered
More FDA Info for this Device
510(K) Number
K211024
Device Name
Pump, Breast, Powered
Applicant
Shantou Huihengqi Electronic Technology Co., Ltd.
501, 5/F, Block C, 14A Industrial Zone, Longhu District
Shantou 515000 CN
Other 510(k) Applications for this Company
Contact
Gensong Yang
Other 510(k) Applications for this Contact
Regulation Number
884.5160
More FDA Info for this Regulation Number
Classification Product Code
HGX
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More FDA Info for this Product Code
Date Received
04/06/2021
Decision Date
02/11/2022
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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