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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, imaging, pulsed echo, ultrasonic
510(k) Number K043275
Device Name OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER
Applicant
OLYMPUS MEDICAL SYSTEMS CORPORATION
TWO CORPORATE CENTER DR.
MELVILLE,  NY  11747 -9058
Applicant Contact LAURA STORMS-TYLER
Correspondent
ENTELA, INC.
3033 MADISON AVENUE, SE
GRAND RAPIDS,  MI  49548
Correspondent Contact NED DEVINE
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received11/26/2004
Decision Date 12/09/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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