FDA 510(k) Application Details - K080809

Device Classification Name	Endoscopic Video Imaging System/Component, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K080809
Device Name	Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Applicant	INNOVATIVE ENDOSCOPY COMPONENTS, LLC. 731-733 SHOTGUN RD. FT. LAUDERDALE, FL 33326 US Other 510(k) Applications for this Company
Contact	GERALD GOIFITZER Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FET Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/21/2008
Decision Date	08/11/2008
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