FDA 510(k) Application Details - K061170

Device Classification Name Coil, Magnetic Resonance, Specialty

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510(K) Number K061170
Device Name Coil, Magnetic Resonance, Specialty
Applicant RESONANCE INNOVATIONS LLC
12530 HARNEY CIRCLE
OMAHA, NE 68154 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 04/27/2006
Decision Date 05/25/2006
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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