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FDA 510(k) Application Details - K013822
Device Classification Name
Pump, Infusion, Pca
More FDA Info for this Device
510(K) Number
K013822
Device Name
Pump, Infusion, Pca
Applicant
CANE SRL
P.O. BOX 7007
DEERFIELD, IL 60015 US
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Contact
DANIEL KAMM, PE
Other 510(k) Applications for this Contact
Regulation Number
880.5725
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Classification Product Code
MEA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/16/2001
Decision Date
05/08/2002
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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