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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystoscope And Accessories, Flexible/Rigid
510(k) Number K993041
Device Name OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIES AND ANCILLARY EQUIPMENT
Applicant
The Olympus Optical Co.
1129 Bloomfield Ave.
West Cadwell,  NJ  07006
Applicant Contact ROBERT SHIFF
Correspondent
The Olympus Optical Co.
1129 Bloomfield Ave.
West Cadwell,  NJ  07006
Correspondent Contact ROBERT SHIFF
Regulation Number876.1500
Classification Product Code
FAJ  
Subsequent Product Codes
FGA   KGE   KNS  
Date Received09/10/1999
Decision Date 03/30/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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