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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
Original Applicant
OLYMPUS MEDICAL SYSTEMS CORP.
3500 corporate parkway
p.o. box 610
center valley,  PA  18034 -0610
Original Contact laura storms-tyler
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   KOG  
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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