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FDA 510(k) Application Details - K041020
Device Classification Name
System, Nuclear Magnetic Resonance Imaging
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510(K) Number
K041020
Device Name
System, Nuclear Magnetic Resonance Imaging
Applicant
CONFIRMA, INC.
821 KIRKLAND AVE.
KIRKLAND, WA 98033-6318 US
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Contact
PATRICIA A MILBANK
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Regulation Number
892.1000
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Classification Product Code
LNH
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More FDA Info for this Product Code
Date Received
04/20/2004
Decision Date
07/07/2004
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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