FDA 510(k) Application Details - K093336

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K093336
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant MEDICAL NUMERICS, INC.
20410 OBSERVATION DRIVE
SUITE 210
GERMANTOWN, MD 20876 US
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Contact DOUGLAS M TUCKER
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 10/26/2009
Decision Date 03/05/2010
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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