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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 K961664
Device Name COMPAT NASOJEJUNAL FEEDING TUBE
Applicant
SANDOZ NUTRITION
1541 PARK PLACE BLVD.
ST. LOUIS PARK,  MN  55416
Applicant Contact ROBERT J LANG
Correspondent
SANDOZ NUTRITION
1541 PARK PLACE BLVD.
ST. LOUIS PARK,  MN  55416
Correspondent Contact ROBERT J LANG
Regulation Number876.5980
Classification Product Code
KNT  
Date Received04/30/1996
Decision Date 10/04/1996
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
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