FDA 510(k) Application Details - K083153

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K083153
Device Name	Tubes, Gastrointestinal (And Accessories)
Applicant	HOLLISTER, INC. 2000 HOLLISTER DR. LIBERTYVILLE, IL 60048 US Other 510(k) Applications for this Company
Contact	CHRIS STUKEL 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	10/24/2008
Decision Date	02/04/2009
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	N
Expedited Review