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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Feeding
510(k) Number K071191
Device Name NOVARTIS COMPAT SURGICAL GASTROSTOMY JEJUNOSTOMY FEEDING TUBE KIT
Applicant
Novartis Nutrition Corp.
1541 Park Place Blvd.
St. Louis Park,  MN  55416
Correspondent
Tuv Sud America, Inc.
1775 Old Highway 8 NW
New Brighton,  MN  55112 -1891
Correspondent Contact LAURA DANIELSON
Regulation Number876.5980
Classification Product Code
FPD  
Date Received04/30/2007
Decision Date 07/23/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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