FDA 510(k) Application Details - K100352

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K100352
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant DIAGNOSOFT, INC.
49 PLAIN STREET
NORTH ATTLEBORO, MA 02760 US
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Contact JEFFREY ROBERTS
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 02/12/2010
Decision Date 03/11/2010
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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