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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 K063683
Device Name OLYMPUS XEU-M60A ENDOSCOPIC ULTRASOUND CENTER; XGF-UM180 ULTRASONIC GASTROVIDEOSCOPE
Applicant
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 CORPORATE PARKWAY
PO BOX 610
CENTER VALLEY,  PA  18034 -0610
Applicant Contact LAURA STORMS-TYLER
Correspondent
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 CORPORATE PARKWAY
PO 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 Received12/12/2006
Decision Date 02/08/2007
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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