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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, Mobile
510(k) Number K953404
Device Name OSTEO-RAY 100
Applicant
Micro Focus Imaging, Inc.
225 Larkin Dr., Unit 1
Wheeling,  IL  60090
Applicant Contact JAMES GRICHNIK
Correspondent
Micro Focus Imaging, Inc.
225 Larkin Dr., Unit 1
Wheeling,  IL  60090
Correspondent Contact JAMES GRICHNIK
Regulation Number892.1720
Classification Product Code
IZL  
Date Received07/20/1995
Decision Date 11/30/1995
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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