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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name colonoscope and accessories, flexible/rigid
510(k) Number K002749
Device Name ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13D
Applicant
THE OLYMPUS OPTICAL CO.
TWO CORPORATE DR.
MELVILLE,  NY  11747
Applicant Contact LAURA STORMS-TYLER
Correspondent
THE OLYMPUS OPTICAL CO.
TWO CORPORATE DR.
MELVILLE,  NY  11747
Correspondent Contact LAURA STORMS-TYLER
Regulation Number876.1500
Classification Product Code
FDF  
Subsequent Product Code
JAB  
Date Received09/05/2000
Decision Date 12/04/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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