FDA 510(k) Application Details - K052023

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K052023
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant ALAN PENN & ASSOCIATES., INC.
6319 MASSACHUSETTS AVENUE
BETHESDA, MD 20816-1139 US
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Contact ROGER H SCHNEIDER
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 07/26/2005
Decision Date 12/08/2005
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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