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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 K060689
Device Name 1.5T PEDIATRIC HEAD AND SPINE ARRAY MODEL
Applicant
Resonance Innovations, LLC
12530 Harney Cir.
Omaha,  NE  68154
Applicant Contact RANDALL JONES
Correspondent
Resonance Innovations, LLC
12530 Harney Cir.
Omaha,  NE  68154
Correspondent Contact RANDALL JONES
Regulation Number892.1000
Classification Product Code
MOS  
Date Received03/15/2006
Decision Date 03/31/2006
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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