FDA 510(k) Application Details - K140606

Device Classification Name Coil, Magnetic Resonance, Specialty

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510(K) Number K140606
Device Name Coil, Magnetic Resonance, Specialty
Applicant RESONANCE INNOVATIONS LLC
9840 S. 140TH ST.
OMAHA, NE 68138-3693 US
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Contact RANDALL JONES
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Regulation Number 892.1000

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Classification Product Code MOS
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Date Received 03/10/2014
Decision Date 05/12/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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