FDA 510(k) Application Details - K014011

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K014011
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant VASSOL, INC.
203 MAIN STREET, PMB 166
FLEMINGTON, NJ 08822 US
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Contact LYNETTE L HOWARD
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 12/05/2001
Decision Date 02/05/2002
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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