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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 K882218
Device Name COMPAT (R) ENTERAL DELIVERY SYSTEM
Original Applicant
SANDOZ NUTRITION
5320 west twenty third st.
p.o. box 370
minneapolis,  MN  55440
Original Contact egberg, ph.d.
Regulation Number876.5980
Classification Product Code
KNT  
Date Received05/26/1988
Decision Date 09/13/1988
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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