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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 K081556
Device Name CADSTREAM, VERSION 5.0
Applicant
Confirma, Inc.
11040 Main St.
Suite 100
Bellevue,  WA  98004
Applicant Contact BRENT LEWIS
Correspondent
Confirma, Inc.
11040 Main St.
Suite 100
Bellevue,  WA  98004
Correspondent Contact BRENT LEWIS
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/03/2008
Decision Date 02/02/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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