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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
Applicant
OSSTEM IMPLANT CO.,LTD
85 ben fairless dr.
fairless hills,  PA  19030
Applicant Contact patrick lim
Correspondent
OSSTEM IMPLANT CO.,LTD
85 ben fairless dr.
fairless hills,  PA  19030
Correspondent 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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