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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Quality-Assurance, Radiologic
510(k) Number K853754
Device Name MAGNETIC RESONANCE IMAGING UNIFORMITY/T1 76-901
Applicant
Victoreen, Inc.
100 Voice Rd.
Carle Place,  NY  11514
Applicant Contact GLASSER
Correspondent
Victoreen, Inc.
100 Voice Rd.
Carle Place,  NY  11514
Correspondent Contact GLASSER
Regulation Number892.1940
Classification Product Code
LHO  
Date Received09/09/1985
Decision Date 05/07/1986
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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