FDA 510(k) Application Details - K992362

Device Classification Name	Endoscopic Video Imaging System/Component, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K992362
Device Name	Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Applicant	SCHOELLY FIBEROPTIC, GMBH 45 PONTIAC RD. NEWTON, MA 02248 US Other 510(k) Applications for this Company
Contact	JOSEPH RESS 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	07/15/1999
Decision Date	08/05/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review