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FDA 510(k) Application Details - K994117
Device Classification Name
System, Nuclear Magnetic Resonance Imaging
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510(K) Number
K994117
Device Name
System, Nuclear Magnetic Resonance Imaging
Applicant
I.Z.I. CORP.
P.O. BOX 4321
CROFTON, MD 21114 US
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Contact
E. J SMITH
Other 510(k) Applications for this Contact
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
12/06/1999
Decision Date
02/04/2000
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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