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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 K903028
Device Name GYREX 2T VERSION 2.1U.
Applicant
Elscint, Inc.
930 Commonwealth Ave.
Boston,  MA  02215
Applicant Contact STEVE BEER
Correspondent
Elscint, Inc.
930 Commonwealth Ave.
Boston,  MA  02215
Correspondent Contact STEVE BEER
Regulation Number892.1000
Classification Product Code
LNH  
Date Received07/11/1990
Decision Date 09/10/1990
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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