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FDA 510(k) Application Details - K110343
Device Classification Name
Pump, Breast, Powered
More FDA Info for this Device
510(K) Number
K110343
Device Name
Pump, Breast, Powered
Applicant
MAYBORN BABY AND CHILD / JACKEL INTERNATIONAL LTD
NORTHUMBERLAND BUSINESS PARK W
CRAMLINGTON, NORTHUMBERLAND NE23 7RH GB
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Contact
NEIL HEWITT
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
02/04/2011
Decision Date
03/11/2011
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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