FDA 510(k) Application Details - K162651

Device Classification Name Coil, Magnetic Resonance, Specialty

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510(K) Number K162651
Device Name Coil, Magnetic Resonance, Specialty
Applicant MORAS MRI products GmbH
Leibnizstr. 4
Hoechberg 97204 DE
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Contact Zahed Sedighiani
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Regulation Number 892.1000

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Classification Product Code MOS
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Date Received 09/23/2016
Decision Date 01/18/2017
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 N
Expedited Review



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