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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Gastrointestinal, Wireless, Capsule
510(k) Number K063259
Device Name OLYMPUS CAPSULE ENDOSCOPE SYSTEM
Applicant
Olympus Medical Systems Corporation
3500 Corporate Pkwy., P.O. Box 610
Center Valley,  PA  18034 -0610
Applicant Contact LAURA STORMS-TYLER
Correspondent
Olympus Medical Systems Corporation
3500 Corporate Pkwy., P.O. Box 610
Center Valley,  PA  18034 -0610
Correspondent Contact LAURA STORMS-TYLER
Regulation Number876.1300
Classification Product Code
NEZ  
Date Received10/30/2006
Decision Date 09/14/2007
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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