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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, Fluoroscopic, Image-Intensified
510(k) Number K926434
Device Name SIS-300(N)-DIA SCAN
Applicant
Micro-Focus Imaging., Inc.
225 Larkin Dr.
Wheeling,  IL  60090
Applicant Contact JIM GRICHNIK
Correspondent
Micro-Focus Imaging., Inc.
225 Larkin Dr.
Wheeling,  IL  60090
Correspondent Contact JIM GRICHNIK
Regulation Number892.1650
Classification Product Code
JAA  
Date Received12/23/1992
Decision Date 03/18/1993
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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