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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Beam Limiting, X-Ray, Diagnostic
510(k) Number K904044
Device Name TF-63SA
Applicant
Toshiba America Medical Systems, In.C
2441 Michelle Dr.
P.O. Box 2068
Tustin,  CA  92781 -2068
Applicant Contact TIMOTHY CAPEHART
Correspondent
Toshiba America Medical Systems, In.C
2441 Michelle Dr.
P.O. Box 2068
Tustin,  CA  92781 -2068
Correspondent Contact TIMOTHY CAPEHART
Regulation Number892.1610
Classification Product Code
KPW  
Date Received09/04/1990
Decision Date 11/29/1990
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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