FDA 510(k) Application Details - K031536

Device Classification Name Coil, Magnetic Resonance, Specialty

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510(K) Number K031536
Device Name Coil, Magnetic Resonance, Specialty
Applicant CLINICAL MR SOLUTIONS, LLC
3735 SHADYBROOK PLACE
BROOKFIELD, WI 53005 US
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Contact RALPH S HASHOIAN
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Regulation Number 892.1000

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Classification Product Code MOS
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Date Received 05/16/2003
Decision Date 07/18/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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