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FDA 510(k) Application Details - K032642
Device Classification Name
Pump, Infusion
More FDA Info for this Device
510(K) Number
K032642
Device Name
Pump, Infusion
Applicant
MCKINLEY, INC.
4080 YOUNGFIELD ST.
WHEAT RIDGE, CO 80033 US
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Contact
ANDY LAMBORNE
Other 510(k) Applications for this Contact
Regulation Number
880.5725
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Classification Product Code
FRN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/27/2003
Decision Date
09/23/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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