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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscopic ultrasound system, gastroenterology-urology
510(k) Number K010591
Device Name OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER
Applicant
OLYMPUS OPTICAL CO., LTD.
2951 ISHIKAWA-CHO
HACHIOJI-SHI
TOKYO,  JP 192-8507
Applicant Contact TSUYOSHI YANAI
Correspondent
TUV PRODUCT SERVICE, INC.
1775 OLD HIGHWAY 8
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact MARK JOB
Regulation Number876.1500
Classification Product Code
ODG  
Date Received02/28/2001
Decision Date 03/15/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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