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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name unit, x-ray, extraoral with timer
510(k) Number K122124
Device Name PORTABLE X-RAY SYSTEM
Original Applicant
OSSTEM IMPLANT CO.,LTD
85 ben fairless dr.
fairless hills,  PA  19030
Original Contact patrick lim
Regulation Number872.1800
Classification Product Code
EHD  
Date Received07/18/2012
Decision Date 05/16/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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