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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Plaque Morphology Evaluation
510(k) Number K093993
Device Name LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70
Applicant
Infraredx, Inc.
34 Third Ave.
Burlington,  MA  01803 -4414
Applicant Contact STEVEN J CHARTIER
Correspondent
Infraredx, Inc.
34 Third Ave.
Burlington,  MA  01803 -4414
Correspondent Contact STEVEN J CHARTIER
Regulation Number870.1200
Classification Product Code
OGZ  
Date Received12/24/2009
Decision Date 06/30/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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