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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 K140606
Device Name 1.5T PROCURE ARRAY COIL, 3.0T PROCURE ARRAY COIL
Applicant
Resonance Innovations, LLC
9840 S. 140th St.
Omaha,  NE  68138 -3693
Applicant Contact RANDALL JONES
Correspondent
Resonance Innovations, LLC
9840 S. 140th St.
Omaha,  NE  68138 -3693
Correspondent Contact RANDALL JONES
Regulation Number892.1000
Classification Product Code
MOS  
Date Received03/10/2014
Decision Date 05/12/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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