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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 K915552
Device Name INSTRUMENTARIUM MEGA4
Applicant
Instrumentarium Imaging, Inc.
300 W. Edgerton Ave.
Milwaukee,  WI  53207
Applicant Contact RICHARD E HALBACH
Correspondent
Instrumentarium Imaging, Inc.
300 W. Edgerton Ave.
Milwaukee,  WI  53207
Correspondent Contact RICHARD E HALBACH
Regulation Number892.1000
Classification Product Code
LNH  
Date Received12/11/1991
Decision Date 02/27/1992
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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