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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, imaging, optical coherence tomography (oct)
510(k) Number K033783
Device Name IMALUX OCT IMAGING SYSTEM
Original Applicant
IMALUX COPORATION
1771 east 30th st.
cleveland,  OH  44114
Original Contact stephanie a.s. harrington
Regulation Number892.1560
Classification Product Code
NQQ  
Date Received12/04/2003
Decision Date 03/01/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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