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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 K133684
Device Name ULTRABLOX
Applicant
BLOXR CORPORATION
960 LEVOY DRIVE
SALT LAKE CITY,  UT  84123
Applicant Contact RAI CHOWDHARY
Correspondent
BLOXR CORPORATION
960 LEVOY DRIVE
SALT LAKE CITY,  UT  84123
Correspondent Contact RAI CHOWDHARY
Classification Product Code
PDK  
Date Received12/02/2013
Decision Date 01/13/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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