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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscopic video imaging system/component, gastroenterology-urology
510(k) Number K041494
Device Name OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2
Applicant
OLYMPUS CORPORATION
TWO CORPORATE CENTER DRIVE
PO BOX 9058
MELVILLE,  NY  11747 -3157
Applicant Contact TINA STEFFANIE-OAK
Correspondent
OLYMPUS CORPORATION
TWO CORPORATE CENTER DRIVE
PO BOX 9058
MELVILLE,  NY  11747 -3157
Correspondent Contact TINA STEFFANIE-OAK
Regulation Number876.1500
Classification Product Code
FET  
Subsequent Product Code
GCJ  
Date Received06/04/2004
Decision Date 07/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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