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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K915567
Device Name MAGNETIC RESONANCE DIAGNOSTIC DEVICE(ACCESORY)
Applicant
FONAR CORP.
110 MARCUS DR.
MELVILLE,  NY  11747
Applicant Contact ANTHONY GIAMBALVO
Correspondent
FONAR CORP.
110 MARCUS DR.
MELVILLE,  NY  11747
Correspondent Contact ANTHONY GIAMBALVO
Regulation Number892.1000
Classification Product Code
LNH  
Date Received12/12/1991
Decision Date 05/15/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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