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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
Original Applicant
DANISH DIAGNOSTIC DEVELOPMENT A/S
dr. neergaardsvej 5f
horsholm,  DA 2970
Original Contact niels sorensen
Regulation Number892.1200
Classification Product Code
KPS  
Date Received06/13/2003
Decision Date 06/20/2003
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Abbreviated
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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