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FDA 510(k) Application Details - K162415
Device Classification Name
Pump, Breast, Powered
More FDA Info for this Device
510(K) Number
K162415
Device Name
Pump, Breast, Powered
Applicant
Uzinmedicare Company
Room 105, Joongang Induspia V, Sagimakgolo 137
Jungwon-gu, Seoungnam-Si
Seoul 13202 KR
Other 510(k) Applications for this Company
Contact
Nathan Ahn
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
08/29/2016
Decision Date
03/15/2017
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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