FDA 510(k) Application Details - K120587

Device Classification Name	Tube, Gastro-Enterostomy   More FDA Info for this Device
510(K) Number	K120587
Device Name	Tube, Gastro-Enterostomy
Applicant	APPLIED MEDICAL TECHNOLOGY, INC. 8000 KATHERINE BOULEVARD BRECKSVILLE, OH 44141 US Other 510(k) Applications for this Company
Contact	ELIZABETH MEYER 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	02/27/2012
Decision Date	05/25/2012
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