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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name generator, high-voltage, x-ray, diagnostic
510(k) Number K904043
Device Name KXO-80C/80D
Applicant
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 MICHELLE DR.
P.O. BOX 2068
TUSTIN,  CA  92781 -2068
Applicant Contact TIMOTHY CAPEHART
Correspondent
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 MICHELLE DR.
P.O. BOX 2068
TUSTIN,  CA  92781 -2068
Correspondent Contact TIMOTHY CAPEHART
Regulation Number892.1700
Classification Product Code
IZO  
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
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