FDA 510(k) Application Details - K961664

Device Classification Name Tubes, Gastrointestinal (And Accessories)

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510(K) Number K961664
Device Name Tubes, Gastrointestinal (And Accessories)
Applicant SANDOZ NUTRITION
1541 PARK PLACE BLVD.
ST. LOUIS PARK, MN 55416 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 04/30/1996
Decision Date 10/04/1996
Decision SESE - SUBST EQUIV
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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