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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, diagnostic
510(k) Number K052908
Device Name INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5
Original Applicant
Infraredx, Inc.
34 third ave
burlington,  MA  01803
Original Contact nandini murthy
Regulation Number870.1200
Classification Product Code
DQO  
Date Received10/14/2005
Decision Date 06/23/2006
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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