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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 K883081
Device Name RADKOR, XG-515
Applicant
Radkor, Inc.
16610 Aston St.
Irvine,  CA  92714
Applicant Contact FRANK A BUZYN
Correspondent
Radkor, Inc.
16610 Aston St.
Irvine,  CA  92714
Correspondent Contact FRANK A BUZYN
Regulation Number892.1700
Classification Product Code
IZO  
Date Received07/21/1988
Decision Date 09/02/1988
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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