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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 K895730
Device Name X-RAY EQUIPMENT (VARIOUS TYPES)
Applicant
Continental X-Ray Corp.
Post Office Box 5571
Chicago,  IL  60680
Applicant Contact ROBERT D WALKER
Correspondent
Continental X-Ray Corp.
Post Office Box 5571
Chicago,  IL  60680
Correspondent Contact ROBERT D WALKER
Regulation Number892.1650
Classification Product Code
JAA  
Date Received09/22/1989
Decision Date 11/06/1989
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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