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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Radiologic
510(k) Number K922098
Device Name CAG-02A
Applicant
Toshiba America Medical Systems, In.C
2441 Michelle Dr.
P.O. Box 2068
Tustin,  CA  92781 -2068
Applicant Contact TIMOTHY W CAPEHART
Correspondent
Toshiba America Medical Systems, In.C
2441 Michelle Dr.
P.O. Box 2068
Tustin,  CA  92781 -2068
Correspondent Contact TIMOTHY W CAPEHART
Regulation Number892.1980
Classification Product Code
KXJ  
Date Received05/06/1992
Decision Date 07/27/1992
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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