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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Changer, Radiographic Film/Cassette
510(k) Number K925598
Device Name BUCKYMATIC AUTOMATIC CHEST FILM CHANGER
Applicant
Acoma Medical Imaging, Inc.
150 Chaddick Dr.
Wheeling,  IL  60090
Applicant Contact JAMES L LAMBRECHT
Correspondent
Acoma Medical Imaging, Inc.
150 Chaddick Dr.
Wheeling,  IL  60090
Correspondent Contact JAMES L LAMBRECHT
Regulation Number892.1860
Classification Product Code
KPX  
Date Received11/05/1992
Decision Date 02/01/1993
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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