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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 K092954
Device Name CADSTREAM VERSION 5
Applicant
CONFIRMA, INC.
11040 MAIN STREET
SUITE 100
BELLEVUE,  WA  98004
Applicant Contact BRENT LEWIS
Correspondent
CONFIRMA, INC.
11040 MAIN STREET
SUITE 100
BELLEVUE,  WA  98004
Correspondent Contact BRENT LEWIS
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/25/2009
Decision Date 11/06/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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