FDA 510(k) Application Details - K092156

Device Classification Name	Endoscopic Access Overtube, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K092156
Device Name	Endoscopic Access Overtube, Gastroenterology-Urology
Applicant	SOFTSCOPE MEDICAL TECHNOLOGIES, INC. 4486 TIMBERLINE CT. VADNAIS HEIGHTS, MN 55127 US Other 510(k) Applications for this Company
Contact	BERNARD HORWATH Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FED Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/16/2009
Decision Date	10/14/2009
Decision	SESE - SUBST EQUIV
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