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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 K853585
Device Name OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS
Applicant
OLYMPUS CORP.
4 NEVADA DR.
lake success,  NY  11042
Applicant Contact terry j hartl
Correspondent
OLYMPUS CORP.
4 NEVADA DR.
lake success,  NY  11042
Correspondent Contact terry j hartl
Regulation Number876.1500
Classification Product Code
FET  
Date Received08/26/1985
Decision Date 01/21/1986
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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