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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 K080340
Device Name COMPAT DUALFLO ENTERAL DELIVERY PUMP SET WITH SPIKERIGHT PIERCING SPIKE AND 1000 ML WAER BAG
Applicant
Novartis Nutrition Corp.
12500 Whitewater Dr.
Minneapolis,  MN  55343
Applicant Contact THOMAS A DOLD
Correspondent
Novartis Nutrition Corp.
12500 Whitewater Dr.
Minneapolis,  MN  55343
Correspondent Contact THOMAS A DOLD
Regulation Number876.5980
Classification Product Code
KNT  
Date Received02/08/2008
Decision Date 03/05/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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