FDA 510(k) Application Details - K100081

Device Classification Name	Endoscopic Access Overtube, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K100081
Device Name	Endoscopic Access Overtube, Gastroenterology-Urology
Applicant	UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY RD. MENTOR, OH 44060 US Other 510(k) Applications for this Company
Contact	BOB BISHUI 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	01/12/2010
Decision Date	04/12/2010
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