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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cream for x-ray attenuation
510(k) Number DEN120022
Device Name X-RAY ATTENUATING CREAM
Original Applicant
BLOXR CORPORATION
960 west levoy drive
suite 100
salt lake city,  UT  84123
Original Contact rai chowdhary
Regulation Number892.6510
Classification Product Code
PDK  
Date Received11/07/2012
Decision Date 05/09/2013
Decision an (AN)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Direct
Reviewed by Third Party No
Combination Product No
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