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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name cream for x-ray attenuation
De Novo Number DEN120022
510(K) Number K123422
Device Name X-RAY ATTENUATING CREAM
Requester
bloxr corporation
960 west levoy drive
suite 100
salt lake city,  UT  84123
Contact rai chowdhary
Regulation Number892.6510
Classification Product Code
PDK  
Date Received11/07/2012
Decision Date 05/09/2013
Decision granted (DENG)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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