FDA 510(k) Application Details - K002016

Device Classification Name

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510(K) Number K002016
Device Name PHILIPS INTEGRIS ALLURA
Applicant PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
VEENPLUIS 4-6
P.O. BOX 10000
5680 DA BEST 5680 NL
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Contact PETER ALTMAN
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Regulation Number

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Classification Product Code OWB
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Date Received 07/03/2000
Decision Date 09/06/2000
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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