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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K061432
Device Name HOSPIRA ENTERAL FEEDING SET, MODEL 20640
Applicant
HOSPIRA, INC.
275 N. FIELD DR., BLDG. H-2
D-389
LAKE FOREST,  IL  60045 -5045
Applicant Contact DIANE RENNPFERD
Correspondent
HOSPIRA, INC.
275 N. FIELD DR., BLDG. H-2
D-389
LAKE FOREST,  IL  60045 -5045
Correspondent Contact DIANE RENNPFERD
Regulation Number876.5980
Classification Product Code
KNT  
Date Received05/24/2006
Decision Date 09/11/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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