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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 K103312
Device Name UPD-Y0003
Applicant
Olympus Medical Systems Corporation
3500 Corporate Pkwy.
P.O. Box 610
Center Valley,  PA  18034
Applicant Contact STACY KLUESNER
Correspondent
Olympus Medical Systems Corporation
3500 Corporate Pkwy.
P.O. Box 610
Center Valley,  PA  18034
Correspondent Contact STACY KLUESNER
Regulation Number876.1500
Classification Product Code
FDF  
Date Received11/10/2010
Decision Date 05/12/2011
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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