FDA 510(k) Application Details - K915598

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K915598
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant ELSCINT, INC.
505 MAIN ST.
SUITE 300
HACKENSACK, NJ US
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Contact ROCHELLE SOBEL
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 12/13/1991
Decision Date 01/31/1992
Decision SE - Substantially Equivalent
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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