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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Central Control Unit
510(k) Number K102763
Device Name SYSTEMS INTEGRATION
Applicant
Olympus Medical Systems Corporation
3500 Corporate Pkwy.
Center Valley,  PA  18034
Applicant Contact STACY ABBATIELLO
Correspondent
Olympus Medical Systems Corporation
3500 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact STACY ABBATIELLO
Regulation Number876.1500
Classification Product Code
ODA  
Subsequent Product Code
GCJ  
Date Received09/24/2010
Decision Date 02/15/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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