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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, Non-Tilting, Powered
510(k) Number K915413
Device Name CAT-250B
Applicant
Toshiba America Medical Systems, In.C
2441 Michelle Dr.
P.O. Box 2068
Tustin,  CA  92781
Applicant Contact TIMOTHY CAPEHART
Correspondent
Toshiba America Medical Systems, In.C
2441 Michelle Dr.
P.O. Box 2068
Tustin,  CA  92781
Correspondent Contact TIMOTHY CAPEHART
Regulation Number892.1980
Classification Product Code
IZZ  
Date Received12/04/1991
Decision Date 12/19/1991
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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