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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 K991668
Device Name COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12)
Applicant
Novartis Nutrition Corp.
5320 W. 23rd St.
P.O. Box 370
Minneapolis,  MN  55440
Applicant Contact ROBERT J LANG
Correspondent
Novartis Nutrition Corp.
5320 W. 23rd St.
P.O. Box 370
Minneapolis,  MN  55440
Correspondent Contact ROBERT J LANG
Regulation Number876.5980
Classification Product Code
KNT  
Date Received05/14/1999
Decision Date 07/26/1999
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
Predetermined Change
Control Plan Authorized		 No
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