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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 K032157
Device Name TELEMIS-MEDICAL SOLUTION
Applicant
Telemis S.A.
7560 Lindbergh Dr.
Gaithersburg,  MD  20879
Applicant Contact THOMAS J BOUCHARD
Correspondent
Telemis S.A.
7560 Lindbergh Dr.
Gaithersburg,  MD  20879
Correspondent Contact THOMAS J BOUCHARD
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/14/2003
Decision Date 09/24/2003
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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