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FDA 510(k) Application Details - K110151
Device Classification Name
System, Nuclear Magnetic Resonance Imaging
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510(K) Number
K110151
Device Name
System, Nuclear Magnetic Resonance Imaging
Applicant
PHILIPS HEALTHCARE
22100 BOTHELL EVERETT HIGHWAY
BOTHELL, WA 98021 US
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Contact
LYNN HARMER
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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
01/18/2011
Decision Date
03/22/2011
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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