FDA 510(k) Application Details - K093312

Device Classification Name	Tube, Gastro-Enterostomy   More FDA Info for this Device
510(K) Number	K093312
Device Name	Tube, Gastro-Enterostomy
Applicant	KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. ROSWELL, GA 30076 US Other 510(k) Applications for this Company
Contact	LESTER PADILLA Other 510(k) Applications for this Contact
Regulation Number	876.5980   More FDA Info for this Regulation Number
Classification Product Code	KGC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/22/2009
Decision Date	12/08/2009
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	Y
Expedited Review