FDA 510(k) Application Details - K041577

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K041577
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant ADAC LABORATORIES
6400 ENTERPRISE LANE,STE.201
MADISON, WI 53719 US
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Contact RANDY VADER
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 06/14/2004
Decision Date 06/25/2004
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 Y
Expedited Review



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