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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system,x-ray,extraoral source,digital
510(k) Number K120975
Device Name CS 8100 CS 8100 ACCESS
Original Applicant
4 rue f. pelloutier croissy
marne la vallee cedex 2,  FR 77437
Original Contact marie-pierre labat-camy
Regulation Number872.1800
Classification Product Code
Date Received04/03/2012
Decision Date 06/22/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No