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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 PARKWAY
CENTER VALLEY,  PA  18034 -0610
Applicant Contact STACY ABBATIELLO
Correspondent
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 CORPORATE PARKWAY
CENTER VALLEY,  PA  18034 -0610
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
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