FDA 510(k) Application Details - K971455

Device Classification Name	Lamp, Endoscope, Incandescent   More FDA Info for this Device
510(K) Number	K971455
Device Name	Lamp, Endoscope, Incandescent
Applicant	CLARUS MEDICAL SYSTEMS, INC. 1000 BOONE AVENUE NORTH #100 MINNEAPOLIS, MN 55427-8656 US Other 510(k) Applications for this Company
Contact	DALE SAPPENFIELD Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FTI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/21/1997
Decision Date	05/20/1997
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