FDA 510(k) Application Details - K051795

Device Classification Name Unit, X-Ray, Extraoral With Timer

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510(K) Number K051795
Device Name Unit, X-Ray, Extraoral With Timer
Applicant ARIBEX, INC.
754 SOUTH 400 EAST
OREM, UT 84097 US
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Contact D.CLARK TURNER
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Regulation Number 872.1800

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Classification Product Code EHD
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Date Received 07/05/2005
Decision Date 07/14/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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