FDA 510(k) Application Details - K130893

Device Classification Name

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510(K) Number K130893
Device Name XPERCT REL. 3
Applicant PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
VEENPLUIS 4-6
BEST 5684 PC NL
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Contact LISELOTTE KORNMANN
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Regulation Number

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Classification Product Code OWB
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Date Received 04/01/2013
Decision Date 09/06/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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