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FDA 510(k) Application Details - K202802
Device Classification Name
Pump, Breast, Powered
More FDA Info for this Device
510(K) Number
K202802
Device Name
Pump, Breast, Powered
Applicant
Wuxi Xinzhongrui Baby Supplies Co., Ltd.
No. 117 Xinhua Road, Meicun, New Wu District,
Wuxi 214000 CN
Other 510(k) Applications for this Company
Contact
Zhang Chunyan
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
09/23/2020
Decision Date
08/26/2021
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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