FDA 510(k) Application Details - K965087

Device Classification Name Tubes, Gastrointestinal (And Accessories)

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510(K) Number K965087
Device Name Tubes, Gastrointestinal (And Accessories)
Applicant SANDOZ NUTRITION
P.O. BOX 370
MINNEAPOLIS, MN 55440 US
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Contact ROBERT J LANG
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Regulation Number 876.5980

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Classification Product Code KNT
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Date Received 12/19/1996
Decision Date 03/18/1997
Decision SESK - SUBST EQUIV - KIT
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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