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FDA 510(k) Application Details - K080048
Device Classification Name
System, Nuclear Magnetic Resonance Imaging
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510(K) Number
K080048
Device Name
System, Nuclear Magnetic Resonance Imaging
Applicant
ONI MEDICAL SYSTEMS, INC.
301 BALLARDVALE ST.
SUITE 4
WILMINGTON, MA 01887 US
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Contact
MARK PUOPOLO
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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
01/08/2008
Decision Date
02/06/2008
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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