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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 K122016
Device Name REXTAR, REXTAR LCD
Original Applicant
META BIOMED, INC.
2600 mullinix mill road
mt. airy,  MD  21771
Original Contact blix winston
Regulation Number872.1800
Classification Product Code
EHD  
Date Received07/10/2012
Decision Date 03/01/2013
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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