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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 K883649
Device Name INSTRUMENTARIUM ULF MR IMAGING SYSTEM MODEL 110H
Applicant
Instrumentarium Corp.
1120 G. St. NW
Washington,  DC  20005
Applicant Contact ROBERT A DORMER
Correspondent
Instrumentarium Corp.
1120 G. St. NW
Washington,  DC  20005
Correspondent Contact ROBERT A DORMER
Regulation Number892.1000
Classification Product Code
LNH  
Date Received08/29/1988
Decision Date 10/19/1988
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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