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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 K112380
Model XSDS-01, XSDS-02, XSDN-01, XSDN-02
Original Applicant
675 heathrow drive
lincolnshire,  IL  60069
Original Contact lisa bartakovics
Regulation Number872.1800
Classification Product Code
Date Received08/17/2011
Decision Date 11/22/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No