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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 K113474
Model NC02100
Device Name 1.5T GEM FLEX COIL
Original Applicant
NEOCOIL, LLC
n27 w23910a paul rd.
pewaukee,  WI  53072
Original Contact steven nichols
Regulation Number892.1000
Classification Product Code
MOS  
Date Received11/22/2011
Decision Date 03/16/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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