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