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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name x-ray, tomography, computed, dental
510(k) Number K121412
Device Name PAX-FLEX3D, PHT-7000
Original Applicant
VATECH CO., LTD.
12946 kimberley ln
houston,  TX  77079
Original Contact dave kim
Regulation Number892.1750
Classification Product Code
OAS  
Date Received05/11/2012
Decision Date 06/08/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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