FDA 510(k) Application Details - K971328

Device Classification Name	System, Water Jet Catheter, Renal   More FDA Info for this Device
510(K) Number	K971328
Device Name	System, Water Jet Catheter, Renal
Applicant	OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. MELVILLE, NY 11747-3157 US Other 510(k) Applications for this Company
Contact	SUBHASH R PATEL Other 510(k) Applications for this Contact
Regulation Number	876.4650   More FDA Info for this Regulation Number
Classification Product Code	FFE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/10/1997
Decision Date	07/01/1997
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