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FDA 510(k) Application Details - K080340
Device Classification Name
Tubes, Gastrointestinal (And Accessories)
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
876.5980
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Classification Product Code
KNT
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More FDA Info for this Product Code
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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