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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 K101053
Device Name OLYMPUS CF TYPE Y0023-L, Y0023I
Applicant
Olympus Medical Systems Corporation
Regulatory Affairs & Quality
3500 Corporate Pkwy.
Center Valley,  PA  18034
Applicant Contact STACY A KLUESNER
Correspondent
Olympus Medical Systems Corporation
Regulatory Affairs & Quality
3500 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact STACY A KLUESNER
Regulation Number876.1500
Classification Product Code
FDF  
Date Received04/15/2010
Decision Date 07/14/2010
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
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