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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Water Jet Catheter, Renal
510(k) Number K971328
Device Name OLYMPUS CD-6C-1 COAGULATION ELECTRODE
Applicant
OLYMPUS AMERICA, INC.
TWO CORPORATE CENTER DR.
MELVILLE,  NY  11747 -3157
Applicant Contact SUBHASH R PATEL
Correspondent
OLYMPUS AMERICA, INC.
TWO CORPORATE CENTER DR.
MELVILLE,  NY  11747 -3157
Correspondent Contact SUBHASH R PATEL
Regulation Number876.4650
Classification Product Code
FFE  
Date Received04/10/1997
Decision Date 07/01/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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