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FDA 510(k) Application Details - K170130
Device Classification Name
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510(K) Number
K170130
Device Name
Dynamic Coronary Roadmap
Applicant
Philips Medical Systems Nederland BV
Veenpluis 4-6
Best 5684PC NL
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Contact
Elaine Alan
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Regulation Number
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Classification Product Code
OWB
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Date Received
01/13/2017
Decision Date
06/02/2017
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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