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FDA 510(k) Application Details - K100929
Device Classification Name
Pump, Breast, Powered
More FDA Info for this Device
510(K) Number
K100929
Device Name
Pump, Breast, Powered
Applicant
BLUE EGG CO
216-5 YONGMOON-DONG, SEO-KU
DAEJON, KOREA KR
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Contact
HONG J HYUN
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
04/05/2010
Decision Date
06/16/2010
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
Y
Expedited Review
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