FDA 510(k) Application Details - K041286

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K041286
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant MRI DEVICES CORP.
1515 PARAMOUNT DR.
WAUKESHA, WI 53186 US
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Contact TOM TYNES
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 05/13/2004
Decision Date 07/21/2004
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 N
Expedited Review



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