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FDA 510(k) Application Details - K133819
Device Classification Name
More FDA Info for this Device
510(K) Number
K133819
Device Name
VERADIUS
Applicant
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
VEENPLUIS 4-6
BEST 5684 PC NL
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Contact
RUOJUAN ZHANG
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
OWB
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More FDA Info for this Product Code
Date Received
12/16/2013
Decision Date
07/10/2014
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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