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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 K031825
Device Name C.CAM
dr. neergaardsvej 5f
horsholm,  DK 2970
Applicant Contact niels sorensen
Regulation Number892.1200
Classification Product Code
Date Received06/13/2003
Decision Date 06/20/2003
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls