FDA 510(k) Application Details - K130706

Device Classification Name Coil, Magnetic Resonance, Specialty

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510(K) Number K130706
Device Name Coil, Magnetic Resonance, Specialty
Applicant MR INSTRUMENTS, INC.
5610 ROWLAND RD.
SUITE 145
MINNEAPOLIS, MN 54343 US
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Contact ROBERT BECK
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Regulation Number 892.1000

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Classification Product Code MOS
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Date Received 03/15/2013
Decision Date 07/25/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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