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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 K902583
Device Name JOINT MOTON IMAGER(TM)
Applicant
Concord Imaging, Ltd.
1670 Cary Rd.
Algonquin,  IL  60102
Applicant Contact CARL GERKEN
Correspondent
Concord Imaging, Ltd.
1670 Cary Rd.
Algonquin,  IL  60102
Correspondent Contact CARL GERKEN
Regulation Number892.1650
Classification Product Code
JAA  
Date Received06/12/1990
Decision Date 09/27/1990
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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