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FDA 510(k) Application Details - K040899
Device Classification Name
Pump, Infusion
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510(K) Number
K040899
Device Name
Pump, Infusion
Applicant
MEDEX, INC.
6250 SHIER RINGS RD.
DUBLIN, OH 40316 US
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Contact
BARBARA LAW
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Regulation Number
880.5725
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Classification Product Code
FRN
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More FDA Info for this Product Code
Date Received
04/06/2004
Decision Date
04/30/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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