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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube Mount, X-Ray, Diagnostic
510(k) Number K941004
Device Name CTS SYSTEM
Applicant
Acoma Medical Imaging, Inc.
150 Chaddick Dr.
Wheeling,  IL  60090
Applicant Contact JAME LAMBRECHT
Correspondent
Acoma Medical Imaging, Inc.
150 Chaddick Dr.
Wheeling,  IL  60090
Correspondent Contact JAME LAMBRECHT
Regulation Number892.1770
Classification Product Code
IYB  
Date Received03/01/1994
Decision Date 07/29/1994
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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