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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, tomography, computed, emission
510(k) Number K051460
Device Name C.CAM-AC
Applicant
DANISH DIAGNOSTIC DEVELOPMENT A/S
DR. NEERGAARDSVEJ 5F
HORSHOLM,  DK
Applicant Contact NIELS SORENSEN
Correspondent
UNDERWRITERS LABORATORIES, INC.
12 LABORATORY DR.
RESEARCH TRIANGLE,  NC  27709
Correspondent Contact JEFFREY D RONGERO
Regulation Number892.1200
Classification Product Code
KPS  
Date Received06/03/2005
Decision Date 06/15/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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