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FDA 510(k) Application Details - K223693
Device Classification Name
Pump, Breast, Powered
More FDA Info for this Device
510(K) Number
K223693
Device Name
Pump, Breast, Powered
Applicant
Shenzhen Lutejiacheng Technology Co., Ltd.
#2-201, Floor 2 Hasee Computer Building, No.2 Beier Rd,
Bantian Street, Longgang
Shenzhen 518129 CN
Other 510(k) Applications for this Company
Contact
Athena Pan
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
12/09/2022
Decision Date
03/09/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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