FDA 510(k) Application Details - K994117

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K994117
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant I.Z.I. CORP.
P.O. BOX 4321
CROFTON, MD 21114 US
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Contact E. J SMITH
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 12/06/1999
Decision Date 02/04/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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