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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, intravascular
510(k) Number K151969
Device Name Hospira Extension Sets
Applicant
ICU Medical Inc
600 N. Field Drive
Lake Forest,  IL  60045
Applicant Contact Charles Neitzel
Correspondent
Hospira, Inc.
375 Field Drive
Lake Forest,  IL  60045
Correspondent Contact Charles Neitzel
Regulation Number880.5440
Classification Product Code
FPA  
Date Received07/16/2015
Decision Date 01/19/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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