FDA 510(k) Application Details - K072574

Device Classification Name System, X-Ray, Tomography, Computed

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510(K) Number K072574
Device Name System, X-Ray, Tomography, Computed
Applicant TAKARA BELMONT CORP.
PO BOX 7007
DEERFIELD, IL 60015 US
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Contact DANIEL KAMM
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Regulation Number 892.1750

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Classification Product Code JAK
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Date Received 09/13/2007
Decision Date 10/18/2007
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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