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FDA 510(k) Application Details - K102344
Device Classification Name
System, Nuclear Magnetic Resonance Imaging
More FDA Info for this Device
510(K) Number
K102344
Device Name
System, Nuclear Magnetic Resonance Imaging
Applicant
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
22100 BOTHELL EVERETT HIGHWAY
BOTHELL, WA 98041-8431 US
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Contact
LYNN HARMER
Other 510(k) Applications for this Contact
Regulation Number
892.1000
More FDA Info for this Regulation Number
Classification Product Code
LNH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/18/2010
Decision Date
11/09/2010
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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