FDA 510(k) Application Details - DEN120022

Device Classification Name

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510(K) Number DEN120022
Device Name X-RAY ATTENUATING CREAM
Applicant BLOXR CORPORATION
960 WEST LEVOY DRIVE
SUITE 100
SALT LAKE CITY, UT 84123 US
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Contact RAI CHOWDHARY
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Regulation Number

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Classification Product Code PDK
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Date Received 11/07/2012
Decision Date 05/09/2013
Decision DENG -
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status
Type Direct
Reviewed By Third Party N
Expedited Review



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