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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 K913407
Device Name NASOJEJUNAL FEEDING TUBE W/GASTRIC DRAINAGE
Applicant
Sandoz Nutrition
5320 W. Twenty Third St.
P.O. Box 370
Minneapolis,  MN  55440
Applicant Contact ROBERT J LANG
Correspondent
Sandoz Nutrition
5320 W. Twenty Third St.
P.O. Box 370
Minneapolis,  MN  55440
Correspondent Contact ROBERT J LANG
Regulation Number876.5980
Classification Product Code
FPD  
Date Received07/30/1991
Decision Date 02/25/1992
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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