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FDA 510(k) Application Details - K122653
Device Classification Name
Tubes, Gastrointestinal (And Accessories)
More FDA Info for this Device
510(K) Number
K122653
Device Name
Tubes, Gastrointestinal (And Accessories)
Applicant
KIMBERLY-CLARK CORPORATION
1400 HOLCOMB BRIDGE RD.
BLDG 300/1
ROSWELL, GA 30076 US
Other 510(k) Applications for this Company
Contact
DAVID LEE
Other 510(k) Applications for this Contact
Regulation Number
876.5980
More FDA Info for this Regulation Number
Classification Product Code
KNT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/31/2012
Decision Date
06/26/2013
Decision
SESK - SUBST EQUIV - KIT
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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