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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, tomography, computed
510(k) Number K032243
Device Name MINICAT DENTOCAT
Original Applicant
XORAN TECHNOLOGIES, INC.
309 n. first street
ann arbor,  MI  48103
Original Contact predrag sukovic
Regulation Number892.1750
Classification Product Code
JAK  
Date Received07/29/2003
Decision Date 10/02/2003
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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