FDA 510(k) Application Details - K032046

Device Classification Name

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510(K) Number K032046
Device Name PHILLIPS OMNIDIAGNOST ELEVA
Applicant PHILIPS MEDICAL SYSTEMS, INC.
VEENPLUIS 4-6
P.O. BOX 10.000
DA BEST 5680 NL
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Contact LYNN HARMER
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Regulation Number

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Classification Product Code OWB
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Date Received 07/02/2003
Decision Date 07/17/2003
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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