FDA 510(k) Application Details - K141979

Device Classification Name

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510(K) Number K141979
Device Name ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES
Applicant PHILIPS MEDICAL SYSTEMS NETHERLAND, B.V.
VEENPLUIS 4-6
5684-PC
BEST NETHERLAND NL
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Contact JEANETTE BECKER
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Regulation Number

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Classification Product Code OWB
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Date Received 07/21/2014
Decision Date 08/19/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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