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FDA 510(k) Application Details - K142708
Device Classification Name
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510(K) Number
K142708
Device Name
VERADIUS UNITY
Applicant
PHILIPS MEDICAL SYSTEMS NETHRLANDS BV
VEENPLUIS 4-6
BEST 5684 PC NL
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Contact
Jeanette Becker
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Regulation Number
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Classification Product Code
OWB
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Date Received
09/22/2014
Decision Date
10/22/2014
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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