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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 K013574
Device Name ACCENT
Applicant
CONFIRMA, INC.
821 KIRKLAND AVE.
KIRKLAND,  WA  98033
Applicant Contact CHERYL SHEA
Correspondent
CONFIRMA, INC.
821 KIRKLAND AVE.
KIRKLAND,  WA  98033
Correspondent Contact CHERYL SHEA
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/29/2001
Decision Date 01/15/2002
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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