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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 K113672
Device Name PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
Original Applicant
VATECH CO., LTD.
12946 kimberley ln
houston,  TX  77079
Original Contact dave kim
Regulation Number872.1800
Classification Product Code
MUH  
Subsequent Product Code
MQB  
Date Received12/13/2011
Decision Date 03/27/2012
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
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