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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 K855098
Device Name COMPAT ENTERAL DELIVERY SYSTEMS
Applicant
SANDOZ NUTRITION
5320 WEST TWENTY THIRD ST.
P.O. BOX 370
MINNEAPOLIS,  MN  55440
Applicant Contact LONGELY PH.D
Correspondent
SANDOZ NUTRITION
5320 WEST TWENTY THIRD ST.
P.O. BOX 370
MINNEAPOLIS,  MN  55440
Correspondent Contact LONGELY PH.D
Regulation Number876.5980
Classification Product Code
KNT  
Date Received12/23/1985
Decision Date 04/08/1986
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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