FDA 510(k) Application Details - K133684

Device Classification Name

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510(K) Number K133684
Device Name ULTRABLOX
Applicant BLOXR CORPORATION
960 LEVOY DRIVE
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 12/02/2013
Decision Date 01/13/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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