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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 K161036
Device Name Hospira Extension Set, Hospira Primary Set
Applicant
HOSPIRA, INC.
375 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  
Subsequent Product Code
ODA  
Date Received04/13/2016
Decision Date 01/06/2017
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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