FDA 510(k) Application Details - K060020

Device Classification Name System, Tomography, Computed, Emission

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510(K) Number K060020
Device Name System, Tomography, Computed, Emission
Applicant ADAC LABORATORIES
540 ALDER DR.
MILPITAS, CA 95035 US
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Contact COLEEN A COLEMAN
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Regulation Number 892.1200

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Classification Product Code KPS
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Date Received 01/04/2006
Decision Date 01/20/2006
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 Y
Expedited Review



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