FDA 510(k) Application Details - K993893

Device Classification Name System, Tomography, Computed, Emission

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510(K) Number K993893
Device Name System, Tomography, Computed, Emission
Applicant MEDX, INC.
3456 NORTH RIDGE AVE., #100
ARLINGTON HEIGHTS, IL 60004 US
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Contact FLOYD ROWAN
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Regulation Number 892.1200

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Classification Product Code KPS
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Date Received 11/16/1999
Decision Date 02/10/2000
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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