FDA 510(k) Application Details - K061622

Device Classification Name	Image, Illumination, Fiberoptic, For Endoscope   More FDA Info for this Device
510(K) Number	K061622
Device Name	Image, Illumination, Fiberoptic, For Endoscope
Applicant	PHOTONIC OPTISCHE GERATE GESMBH & COKG SEEBOCKGASSE 59 VIENNA A-1160 AT Other 510(k) Applications for this Company
Contact	DIETER FEGER Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FFS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/12/2006
Decision Date	03/05/2007
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	Y
Expedited Review