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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 K052722
Device Name LIFESHIELD LATEX-FREE MICROBORE EXTENSION SET, MODEL 14949 AND OTHERS
Applicant
HOSPIRA, INC.
275 NORTH FIELD DR.
LAKE FOREST,  IL  60045
Applicant Contact THOMAS KOZMA
Correspondent
HOSPIRA, INC.
275 NORTH FIELD DR.
LAKE FOREST,  IL  60045
Correspondent Contact THOMAS KOZMA
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
FPK  
Date Received09/29/2005
Decision Date 11/02/2005
Decision SE - With Limitations (SESU)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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