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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 K133986
Device Name 1.5T ORBIT AND MANDIBLE ARRAY, 3.0T ORBIT AND MANDIBLE ARRAY
Applicant
RESONANCE INNOVATIONS LLC
9840 S 140th St Ste 8
OMAHA,  NE  68138
Applicant Contact RANDALL JONES
Correspondent
RESONANCE INNOVATIONS LLC
9840 S 140th St Ste 8
OMAHA,  NE  68138
Correspondent Contact RANDALL JONES
Regulation Number892.1000
Classification Product Code
MOS  
Date Received12/26/2013
Decision Date 01/27/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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