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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, Tomography, Computed
510(k) Number K881305
Device Name TCT-300S COMPUTED TOMO. (CT) X-RAY SYSTEM FOR EXAM
Applicant
Toshiba Medical Systems
2441 Michelle
P.O. Box 2068
Tustin,  CA  92680
Applicant Contact RONALD SCHILLING,PHD
Correspondent
Toshiba Medical Systems
2441 Michelle
P.O. Box 2068
Tustin,  CA  92680
Correspondent Contact RONALD SCHILLING,PHD
Regulation Number892.1750
Classification Product Code
JAK  
Date Received03/28/1988
Decision Date 10/19/1988
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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