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FDA 510(k) Application Details - K011466
Device Classification Name
System, Nuclear Magnetic Resonance Imaging
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510(K) Number
K011466
Device Name
System, Nuclear Magnetic Resonance Imaging
Applicant
SUN NUCLEAR CORP.
425-A PINEDA COURT
MELBOURNE, FL 32940 US
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Contact
JIM MIXON
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
05/14/2001
Decision Date
06/06/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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