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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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