FDA 510(k) Application Details - K080340

Device Classification Name Tubes, Gastrointestinal (And Accessories)

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510(K) Number K080340
Device Name Tubes, Gastrointestinal (And Accessories)
Applicant NOVARTIS NUTRITION CORP.
12500 WHITEWATER DRIVE
MINNETONKA, MN 55343 US
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Contact THOMAS A DOLD
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Regulation Number 876.5980

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Classification Product Code KNT
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Date Received 02/08/2008
Decision Date 03/05/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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