FDA 510(k) Application Details - K981856

Device Classification Name	Endoscopic Video Imaging System/Component, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K981856
Device Name	Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Applicant	GREATBATCH SCIENTIFIC 9645 WEHRLE DR. CLARENCE, NY 14031-1899 US Other 510(k) Applications for this Company
Contact	GARY J SFEIR 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	05/27/1998
Decision Date	07/29/1998
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