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FDA 510(k) Application Details - K071191
Device Classification Name
Tube, Feeding
More FDA Info for this Device
510(K) Number
K071191
Device Name
Tube, Feeding
Applicant
NOVARTIS NUTRITION CORP.
1541 PARK PLACE BLVD.
ST. LOUIS PARK, MN 55416 US
Other 510(k) Applications for this Company
Regulation Number
876.5980
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Classification Product Code
FPD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/30/2007
Decision Date
07/23/2007
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
Y
Expedited Review
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