FDA 510(k) Application Details - K083578

Device Classification Name Coil, Magnetic Resonance, Specialty

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510(K) Number K083578
Device Name Coil, Magnetic Resonance, Specialty
Applicant NORAS MRI PRODUCTS GMBH
LEIBNITZSTRASSE 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 12/03/2008
Decision Date 01/16/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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