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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 K893540
Device Name VINYL BAG W/PUMP ADMINISTRATION SET
Applicant
SANDOZ NUTRITION
5320 WEST TWENTY THIRD ST.
P.O. BOX 370
MINNEAPOLIS,  MN  55440
Applicant Contact EGBERG, PHD
Correspondent
SANDOZ NUTRITION
5320 WEST TWENTY THIRD ST.
P.O. BOX 370
MINNEAPOLIS,  MN  55440
Correspondent Contact EGBERG, PHD
Regulation Number876.5980
Classification Product Code
KNT  
Date Received05/08/1989
Decision Date 10/17/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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