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FDA 510(k) Application Details - K032046
Device Classification Name
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
OWB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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