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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K960985
Device Name SLS-CT
Applicant
Bio-Imaging Research, Inc.
425 Barclay Blvd.
Lincolnshire,  IL  60069
Applicant Contact DONALD BARHAM
Correspondent
Bio-Imaging Research, Inc.
425 Barclay Blvd.
Lincolnshire,  IL  60069
Correspondent Contact DONALD BARHAM
Regulation Number892.1750
Classification Product Code
JAK  
Date Received02/29/1996
Decision Date 10/25/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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