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FDA 510(k) Application Details - K172307
Device Classification Name
More FDA Info for this Device
510(K) Number
K172307
Device Name
Dynamic Coronary Roadmap 2.0
Applicant
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best 5684 PC NL
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Contact
Laura Wortel
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
OWB
Other 510(k) Applications for this Device
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Date Received
07/31/2017
Decision Date
10/24/2017
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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