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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, Angiographic
510(k) Number K944952
Device Name ANGIOGRAPHIC SYSTEM
Applicant
Acoma Medical Imaging, Inc.
150 Chaddick Dr.
Wheeling,  IL  60090
Applicant Contact JAMES LAMBRECHT
Correspondent
Acoma Medical Imaging, Inc.
150 Chaddick Dr.
Wheeling,  IL  60090
Correspondent Contact JAMES LAMBRECHT
Regulation Number892.1600
Classification Product Code
IZI  
Date Received10/07/1994
Decision Date 02/17/1995
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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