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FDA 510(k) Application Details - K073362
Device Classification Name
System, Nuclear Magnetic Resonance Imaging
More FDA Info for this Device
510(K) Number
K073362
Device Name
System, Nuclear Magnetic Resonance Imaging
Applicant
PARAMED SRL
39 HIGH STREET
NORTH ANDOVER, MA 01845 US
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Contact
MICHAEL A DOUGLAS
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
11/30/2007
Decision Date
05/23/2008
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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