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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
Device Name 1.5T GEM FLEX COIL
Original Applicant
n27 w23910a paul rd.
pewaukee,  WI  53072
Original Contact steven nichols
Regulation Number892.1000
Classification Product Code
Date Received11/22/2011
Decision Date 03/16/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No