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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
Original Applicant
2441 michelle dr.
p.o. box 2068
tustin,  CA  92781 -2068
Original Contact timothy capehart
Regulation Number892.1700
Classification Product Code
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