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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