FDA 510(k) Application Details - K110804

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K110804
Device Name	Tubes, Gastrointestinal (And Accessories)
Applicant	APPLIED MEDICAL TECHNOLOGY, INC. 8000 KATHERINE BOULEVARD BRECKSVILLE, OH 44141 US Other 510(k) Applications for this Company
Contact	JOSHUA D MEINKE 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	03/22/2011
Decision Date	10/19/2011
Decision	SESK - SUBST EQUIV - KIT
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review