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FDA 510(k) Application Details - K033290
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K033290
Device Name
Set, Administration, Intravascular
Applicant
ICU MEDICAL, INC.
951 CALLE AMANECER
SAN CLEMENTE, CA 92673 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
10/14/2003
Decision Date
04/12/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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