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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name coil, magnetic resonance, specialty
510(k) Number K121249
Device Name MULTIARRAY KIT
Original Applicant
PARAMED SRL
corso perrone 73r
genova,  IT 16152
Original Contact luisella de benedetti
Regulation Number892.1000
Classification Product Code
MOS  
Date Received04/25/2012
Decision Date 06/12/2012
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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