FDA 510(k) Application Details - K971982

Device Classification Name	System, Irrigation, Urological   More FDA Info for this Device
510(K) Number	K971982
Device Name	System, Irrigation, Urological
Applicant	KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE CULVER CITY, CA 90230-7600 US Other 510(k) Applications for this Company
Contact	KEVIN A KENNAN Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LJH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/29/1997
Decision Date	08/12/1997
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