FDA 510(k) Application Details - K132087

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

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510(K) Number K132087
Device Name System, X-Ray, Tomography, Computed
Applicant PHILIPS HEALTHCARE
49 SPADINA AVENUE
#310
TORONTO M5V 2J1 CA
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Contact DAVE SZCZUPAKOWSKI
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Regulation Number 892.1750

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Classification Product Code JAK
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Date Received 07/05/2013
Decision Date 07/24/2013
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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