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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Biopsy, Non-Electric
510(k) Number K032092
Device Name OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE
Applicant
Olympus Optical Co., Ltd.
34-3 Hirai, Hinode-Machi
Nishitama-Gun Tokyo,  JP 190-0182
Applicant Contact MASAO WADA
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DERWYN REUBER
Regulation Number876.1075
Classification Product Code
FCL  
Subsequent Product Codes
FAJ   FDI   FGA   KGE   KNS  
Date Received07/07/2003
Decision Date 07/16/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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