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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 Doppler, Ultrasonic
510(k) Number K121564
Device Name ENDOSCOPIC ULTRASOUND CENTER EU-Y0006
Applicant
Olympus Medical Systems Corp.
3500 Corporate Pkwy., P.O. Box 610
Center Valley,  PA  18034 -0610
Applicant Contact LAURA STORMS-TYLER
Correspondent
Olympus Medical Systems Corp.
3500 Corporate Pkwy., P.O. Box 610
Center Valley,  PA  18034 -0610
Correspondent Contact LAURA STORMS-TYLER
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   ODG  
Date Received05/29/2012
Decision Date 10/16/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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