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FDA 510(k) Application Details - K112268
Device Classification Name
Tubes, Gastrointestinal (And Accessories)
More FDA Info for this Device
510(K) Number
K112268
Device Name
Tubes, Gastrointestinal (And Accessories)
Applicant
CODAN US CORP.
3511 WEST SUNFLOWER AVE.
SANTA ANA, CA 92704-6944 US
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Contact
JEFF NIELSEN
Other 510(k) Applications for this Contact
Regulation Number
876.5980
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Classification Product Code
KNT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/08/2011
Decision Date
03/19/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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