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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 K904528
Device Name INSTRUMENTARIUM MEGA4, MODIFICATION
Applicant
Instrumentarium Imaging, Inc.
300 W. Edgerton Ave.
Milwaukee,  WI  53207
Applicant Contact GARY BUSS
Correspondent
Instrumentarium Imaging, Inc.
300 W. Edgerton Ave.
Milwaukee,  WI  53207
Correspondent Contact GARY BUSS
Regulation Number892.1000
Classification Product Code
LNH  
Date Received10/01/1990
Decision Date 11/20/1990
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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