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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, nuclear magnetic resonance imaging
510(k) Number K122034
Model 06-2000-00
Device Name MRJ 3300
Original Applicant
PARAMED SRL
corso f.m. perrone 73r
genoa,  IT 16152
Original Contact luisella debenedetti
Regulation Number892.1000
Classification Product Code
LNH  
Date Received07/11/2012
Decision Date 12/06/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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