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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 PARKWAY
P.O. BOX 610
CENTER VALLEY,  PA  18034 -0610
Applicant Contact LAURA STORMS-TYLER
Correspondent
OLYMPUS MEDICAL SYSTEMS CORP.
3500 CORPORATE PARKWAY
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
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