FDA 510(k) Application Details - K003453

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K003453
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant FONAR CORP.
110 MARCUS DR., 102 MARCUS DR.
& 405 SMITH ST.
MELVILLE, NY 11747 US
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Contact LUCIANO BONANNI
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 11/07/2000
Decision Date 01/18/2001
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

FDA Source Information for K003453


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