FDA 510(k) Application Details - K113062

Device Classification Name	Telescope, Rigid, Endoscopic   More FDA Info for this Device
510(K) Number	K113062
Device Name	Telescope, Rigid, Endoscopic
Applicant	ENDOSERVICE OPTICAL INSTRUMENTS GMBH SCHWARZWALDSTRASSE 5 TUTTLINGEN 78532 DE Other 510(k) Applications for this Company
Contact	ANDREA PECSI Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FBP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/14/2011
Decision Date	08/21/2012
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