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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Led Light Source
510(k) Number K122831
FOIA Releasable 510(k) K122831
Device Name VIDEO SYSTEM CENTER
Applicant
Olympus Medical Systems Corp.
3500 Corporate Pkwy., P.O. Box 610
Center Valley,  PA  18034 -0610
Applicant Contact SHERI L MUSGNUNG
Correspondent
Olympus Medical Systems Corp.
3500 Corporate Pkwy., P.O. Box 610
Center Valley,  PA  18034 -0610
Correspondent Contact SHERI L MUSGNUNG
Regulation Number876.1500
Classification Product Code
NTN  
Subsequent Product Codes
FET   NWB  
Date Received09/17/2012
Decision Date 12/14/2012
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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