FDA 510(k) Application Details - K033507

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K033507
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant PARAMED SRL
719 CATALPA AVENUE
TEANECK, NJ 07666 US
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Contact DIANA UPTON
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 11/05/2003
Decision Date 01/20/2004
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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