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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K090603
Device Name BARCO 5MP MAMMO, MODEL MDMG-5221
Applicant
Barco N.V.
15425 SW Beaverton Creek Ct.
Beaverton,  OR  97006
Applicant Contact ALBERT XTHONA
Correspondent
Barco N.V.
15425 SW Beaverton Creek Ct.
Beaverton,  OR  97006
Correspondent Contact ALBERT XTHONA
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/05/2009
Decision Date 04/22/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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