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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubing, Fluid Delivery
510(k) Number K063239
Device Name LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526
Applicant
HOSPIRA, INC.
275 NORTH FIELD DR.
DEPT. 389, BLDG. H2
LAKE FOREST,  IL  60045
Applicant Contact DIANE RENNPFERD
Correspondent
HOSPIRA, INC.
275 NORTH FIELD DR.
DEPT. 389, BLDG. H2
LAKE FOREST,  IL  60045
Correspondent Contact DIANE RENNPFERD
Regulation Number880.5440
Classification Product Code
FPK  
Subsequent Product Code
FPA  
Date Received10/26/2006
Decision Date 12/11/2006
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
Recalls CDRH Recalls
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