FDA 510(k) Application Details - K982993

Device Classification Name

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510(K) Number K982993
Device Name PHILIPS OMNIDIAGNOST
Applicant PHILIPS MEDICAL SYSTEMS, INC.
VEENPLUIS 4-6
P.O. BOX 10.000
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 08/27/1998
Decision Date 09/29/1998
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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