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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 K121800
Device Name POINT 500 HD POINT500C HD
Applicant
POINTNIX CO., LTD
55 northern blvd
great neck,  NY  11021
Contact jigar shah
Regulation Number872.1800
Classification Product Code
MUH  
Date Received06/19/2012
Decision Date 01/24/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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