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FDA 510(k) Application Details - K961366
Device Classification Name
System, Nuclear Magnetic Resonance Imaging
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510(K) Number
K961366
Device Name
System, Nuclear Magnetic Resonance Imaging
Applicant
MRI DEVICES CORP.
N8 W22520 JOHNSON DR., UNIT K
JOHNSON DR., CORPORATE CENTER
WAUKESHA, WI 53186 US
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Contact
THOMAS SCHUBERT
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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
04/09/1996
Decision Date
07/03/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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