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FDA 510(k) Application Details - K042228
Device Classification Name
Pump, Infusion
More FDA Info for this Device
510(K) Number
K042228
Device Name
Pump, Infusion
Applicant
MCKINLEY, INC.
4080 YOUNGFIELD ST.
WHEAT RIDGE, CO 80033 US
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Contact
MICHELLE PRATTE
Other 510(k) Applications for this Contact
Regulation Number
880.5725
More FDA Info for this Regulation Number
Classification Product Code
FRN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/17/2004
Decision Date
11/08/2004
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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