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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, High-Voltage, X-Ray, Diagnostic
510(k) Number K833846
Device Name PROCESS 100 ST
Applicant
Cgr Medical Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Cgr Medical Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number892.1700
Classification Product Code
IZO  
Date Received09/15/1983
Decision Date 12/16/1983
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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