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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 K912963
Device Name INSTRUMENTARIUM MEGA4
Applicant
Instrumentarium Imaging, Inc.
300 W. Edgerton Ave.
Milwaukee,  WI  53207
Applicant Contact RICHARD HALBACH,PH.D
Correspondent
Instrumentarium Imaging, Inc.
300 W. Edgerton Ave.
Milwaukee,  WI  53207
Correspondent Contact RICHARD HALBACH,PH.D
Regulation Number892.1000
Classification Product Code
LNH  
Date Received07/08/1991
Decision Date 09/30/1991
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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