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FDA 510(k) Application Details - K150476
Device Classification Name
Pump, Breast, Powered
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510(K) Number
K150476
Device Name
Pump, Breast, Powered
Applicant
UZINMEDICARE CO.
Rm 105, Joongang Induspia V, Sagimakgolo 137
Jungwon-gu 462-807 KR
Other 510(k) Applications for this Company
Contact
Ho Jun Kang
Other 510(k) Applications for this Contact
Regulation Number
884.5160
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Classification Product Code
HGX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/24/2015
Decision Date
04/15/2016
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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