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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Radiographic, Stationary Top
510(k) Number K892196
Device Name RADKOR TS10-B
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 Number892.1980
Classification Product Code
IXQ  
Date Received04/03/1989
Decision Date 04/26/1989
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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