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FDA 510(k) Application Details - K984221
Device Classification Name
System, Nuclear Magnetic Resonance Imaging
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510(K) Number
K984221
Device Name
System, Nuclear Magnetic Resonance Imaging
Applicant
SIEMENS CORP.
186 WOOD AVE., SOUTH
ISELIN, NJ 08830 US
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Contact
KATHLEEN RUTHERFORD
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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
11/25/1998
Decision Date
02/12/1999
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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