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FDA 510(k) Application Details - K123108
Device Classification Name
Catheter, Intravascular, Plaque Morphology Evaluation
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510(K) Number
K123108
Device Name
Catheter, Intravascular, Plaque Morphology Evaluation
Applicant
Infraredx, Inc.
34 Third Avenue
Burlington, MA 01803 US
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Contact
STEVEN J CHARTIER
Other 510(k) Applications for this Contact
Regulation Number
870.1200
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Classification Product Code
OGZ
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More FDA Info for this Product Code
Date Received
10/03/2012
Decision Date
03/15/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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