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FDA 510(k) Application Details - K041410
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K041410
Device Name
Set, Administration, Intravascular
Applicant
ICU MEDICAL INC
129 RESERVOIR RD.
VERNON, CT 06066-5705 US
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Contact
DALE FAIRCHILD
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
FPA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/27/2004
Decision Date
07/28/2004
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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