FDA 510(k) Application Details - K092253

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K092253
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant NORDICNEUROLAB
MOLLENDALSVEIEN 65C
BERGEN N-5009 NO
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Contact CHANDANA GURUNG BHANDARI
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 07/28/2009
Decision Date 10/08/2009
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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