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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 K021913
Device Name CALSCOR SOFTWARE
Applicant
3D MED CO., LTD.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact MARY MCNAMARA-CULLINANE
Correspondent
3D MED CO., LTD.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact MARY MCNAMARA-CULLINANE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/11/2002
Decision Date 09/06/2002
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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