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FDA 510(k) Application Details - K013087
Device Classification Name
Set, I.V. Fluid Transfer
More FDA Info for this Device
510(K) Number
K013087
Device Name
Set, I.V. Fluid Transfer
Applicant
ALARIS MEDICAL SYSTEMS, INC.
10221 WATERIDGE CIR.
SAN DIEGO, CA 92121-2733 US
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Contact
RENEE L FLUET
Other 510(k) Applications for this Contact
Regulation Number
880.5440
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Classification Product Code
LHI
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More FDA Info for this Product Code
Date Received
09/17/2001
Decision Date
11/13/2001
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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