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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, Non-Image-Intensified
510(k) Number K813032
Device Name ZIKON 100 DIGITAL X-RAY SYSTEM
Applicant
Kontron Instruments, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Kontron Instruments, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number892.1660
Classification Product Code
JAB  
Date Received10/28/1981
Decision Date 11/24/1981
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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